Data / Medical devices / United States / Jmu Dental, Inc

Jmu Dental, Inc: FDA-registered device maker in Fullerton, CA, United States, 52 510(k) clearances

Name: Jmu Dental, Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jmu Dental, Inc is registered with the FDA (registration 3014683120) in Fullerton, CA, United States. It lists 149 device types. The FDA files 52 510(k) clearances under its listings, the newest dated May 29, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Jmu Dental, Inc

FDA registration number: 3014683120
Address: 150 E Lambert Rd, Fullerton, CA, United States, 92835
Owner or operator: JMU DENTAL, INC (10058141)
Roles: Repackager or relabeler
First device listed: May 14, 2015
Registered through: 2027
Brand names listed: ,D600 LED;, 1st Molar Rough Band w/ MBT Tube, 1st Molar Rough Band w/ Roth Tube, A-Silicone Bite Registration Material, ABSORBENT TIPPED APPLICATOR, AIR COMPRESSOR AND VACUUM UNIT; BARRIER FILM; HANDPIECE SLEEVES; INSTRUMENT TRAY SLEEVES; LIGHT/SENSOR SLEEVES/ POUCHES;, Adhesive, Resin, Composite, Apex Locator and more

Devices it lists

Device	Product code	Class	Role	Source
Absorber, Saliva, Paper	KHR	1	Repackager or relabeler	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Repackager or relabeler	accessdata.fda.gov
Accessories, Retractor, Dental	EIF	1	Repackager or relabeler	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Repackager or relabeler	accessdata.fda.gov
Activator, Ultraviolet, For Polymerization	EBZ	2	Repackager or relabeler	accessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Repackager or relabeler	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Repackager or relabeler	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Repackager or relabeler	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Repackager or relabeler	accessdata.fda.gov
Applicator, Resin	KXR	1	Repackager or relabeler	accessdata.fda.gov
Apron, Leaded	EAJ	1	Repackager or relabeler	accessdata.fda.gov
Articulators	EJP	1	Repackager or relabeler	accessdata.fda.gov
Band, Elastic, Orthodontic	ECI	1	Repackager or relabeler	accessdata.fda.gov
Band, Preformed, Orthodontic	ECM	1	Repackager or relabeler	accessdata.fda.gov
Basin, Emesis	FNY	1	Repackager or relabeler	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Repackager or relabeler	accessdata.fda.gov
Bedpan	FOB	1	Repackager or relabeler	accessdata.fda.gov
Blade, Scalpel	GES	1	Repackager or relabeler	accessdata.fda.gov
Bracket, Metal, Orthodontic	EJF	1	Repackager or relabeler	accessdata.fda.gov
Bur, Dental	EJL	1	Repackager or relabeler	accessdata.fda.gov
Camera, Cine, Endoscopic, With Audio	FTS	1	Repackager or relabeler	accessdata.fda.gov
Camera, Television, Endoscopic, Without Audio	FWF	1	Repackager or relabeler	accessdata.fda.gov
Cap, Surgical	FYF	1	Repackager or relabeler	accessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)	BZN	1	Repackager or relabeler	accessdata.fda.gov
Carver, Dental Amalgam, Operative	EKH	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Repackager or relabeler	accessdata.fda.gov
Cement, Dental	EMA	2	Repackager or relabeler	accessdata.fda.gov
Chair, Adjustable, Mechanical	INN	1	Repackager or relabeler	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Repackager or relabeler	accessdata.fda.gov
Chair, Examination And Treatment	FRK	1	Repackager or relabeler	accessdata.fda.gov
Clamp, Rubber Dam	EEF	1	Repackager or relabeler	accessdata.fda.gov
Clamp, Wire, Orthodontic	ECN	1	Repackager or relabeler	accessdata.fda.gov
Cleaner, Denture, Mechanical	JER	1	Repackager or relabeler	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Repackager or relabeler	accessdata.fda.gov
Container, Sharps	MMK	2	Repackager or relabeler	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Repackager or relabeler	accessdata.fda.gov
Controller, Foot, Handpiece And Cord	EBW	1	Repackager or relabeler	accessdata.fda.gov
Cotton, Roll	EFN	1	Repackager or relabeler	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Repackager or relabeler	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Repackager or relabeler	accessdata.fda.gov
Cutter, Wire	HXZ	1	Repackager or relabeler	accessdata.fda.gov
Dam, Rubber	EIE	1	Repackager or relabeler	accessdata.fda.gov
Dental Barriers And Sleeves	PEM	2	Repackager or relabeler	accessdata.fda.gov
Denture, Plastic, Teeth	ELM	2	Repackager or relabeler	accessdata.fda.gov
Depressor, Metal Tongue, Surgical	KBL	1	Repackager or relabeler	accessdata.fda.gov
Depressor, Tongue, Non-Surgical	FMA	1	Repackager or relabeler	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Repackager or relabeler	accessdata.fda.gov
Dispenser, Solid Medication	NXB	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Compression	MHW	1	Repackager or relabeler	accessdata.fda.gov
Drill, Bone, Powered	DZI	2	Repackager or relabeler	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Repackager or relabeler	accessdata.fda.gov
Dynamometer, Nonpowered	HRW	1	Repackager or relabeler	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Repackager or relabeler	accessdata.fda.gov
Evacuator, Oral Cavity	EHZ	1	Repackager or relabeler	accessdata.fda.gov
Facebow	KCR	1	Repackager or relabeler	accessdata.fda.gov
Fentanyl And Other Opioid Protection Glove	QDO	1	Repackager or relabeler	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Repackager or relabeler	accessdata.fda.gov
Film, Radiographic	IWZ	1	Repackager or relabeler	accessdata.fda.gov
Finger Cot	LZB	1	Repackager or relabeler	accessdata.fda.gov
Floss, Dental	JES	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Dressing, Dental	EFL	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Rongeur, Surgical	EMH	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Tooth Extractor, Surgical	EMG	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Gown, Examination	FME	1	Repackager or relabeler	accessdata.fda.gov
Gutta-Percha	EKM	1	Repackager or relabeler	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Repackager or relabeler	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Rotary Bone Cutting	KMW	2	Repackager or relabeler	accessdata.fda.gov
Heat Source For Bleaching Teeth	EEG	1	Repackager or relabeler	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Repackager or relabeler	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Filling, Plastic, Dental	EIY	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Repackager or relabeler	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Repackager or relabeler	accessdata.fda.gov
Latex Patient Examination Glove	LYY	1	Repackager or relabeler	accessdata.fda.gov
Light, Microscope	IBJ	1	Repackager or relabeler	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Repackager or relabeler	accessdata.fda.gov
Locator, Root Apex	LQY	U	Repackager or relabeler	accessdata.fda.gov
Loupe, Binocular, Low Power	HJH	1	Repackager or relabeler	accessdata.fda.gov
Loupe, Diagnostic/Surgical	FSP	1	Repackager or relabeler	accessdata.fda.gov
Mask, Scavenging	KHA	1	Repackager or relabeler	accessdata.fda.gov
Mask, Surgical	FXX	2	Repackager or relabeler	accessdata.fda.gov
Material, Impression	ELW	2	Repackager or relabeler	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Repackager or relabeler	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Repackager or relabeler	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Repackager or relabeler	accessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	1	Repackager or relabeler	accessdata.fda.gov
Microscope, Surgical, General & Plastic Surgery	FSO	1	Repackager or relabeler	accessdata.fda.gov
Mirror, Mouth	EAX	1	Repackager or relabeler	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Repackager or relabeler	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Repackager or relabeler	accessdata.fda.gov
Needle, Dental	DZM	1	Repackager or relabeler	accessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2	Repackager or relabeler	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Repackager or relabeler	accessdata.fda.gov
Paper, Articulation	EFH	1	Repackager or relabeler	accessdata.fda.gov
Parallelometer	EGI	1	Repackager or relabeler	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Repackager or relabeler	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Repackager or relabeler	accessdata.fda.gov
Point, Abrasive	EHL	1	Repackager or relabeler	accessdata.fda.gov
Point, Paper, Endodontic	EKN	1	Repackager or relabeler	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Repackager or relabeler	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Repackager or relabeler	accessdata.fda.gov
Powder, Porcelain	EIH	2	Repackager or relabeler	accessdata.fda.gov
Protector, Dental	BRW	1	Repackager or relabeler	accessdata.fda.gov
Pusher, Band, Orthodontic	ECS	1	Repackager or relabeler	accessdata.fda.gov
Retainer, Matrix	JEP	1	Repackager or relabeler	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Repackager or relabeler	accessdata.fda.gov
Retainer, Surgical	GCZ	1	Repackager or relabeler	accessdata.fda.gov
Retractor, All Types	EIG	1	Repackager or relabeler	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Repackager or relabeler	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Repackager or relabeler	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Surgical Tissue, Dental	EGN	1	Repackager or relabeler	accessdata.fda.gov
Scraper, Tongue	LCN	1	Repackager or relabeler	accessdata.fda.gov
Screwdriver	HXX	1	Repackager or relabeler	accessdata.fda.gov
Setter, Band, Orthodontic	ECR	1	Repackager or relabeler	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Repackager or relabeler	accessdata.fda.gov
Spreader, Pulp Canal Filling Material, Endodontic	EKK	1	Repackager or relabeler	accessdata.fda.gov
Spring, Orthodontic	ECO	1	Repackager or relabeler	accessdata.fda.gov
Stool, Operating-Room	FZM	1	Repackager or relabeler	accessdata.fda.gov
Strip, Polishing Agent	EHM	1	Repackager or relabeler	accessdata.fda.gov
Syringe, Cartridge	EJI	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Irrigating (Dental)	EIB	1	Repackager or relabeler	accessdata.fda.gov
Syringe, Periodontic, Endodontic, Irrigating	EIC	1	Repackager or relabeler	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Repackager or relabeler	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Repackager or relabeler	accessdata.fda.gov
Tip, Rubber, Oral Hygiene	JEW	1	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Repackager or relabeler	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Repackager or relabeler	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Ent	MMO	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	accessdata.fda.gov
Tube Impression And Matrix	KCQ	1	Repackager or relabeler	accessdata.fda.gov
Tube, Orthodontic	DZD	1	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Repackager or relabeler	accessdata.fda.gov
Unit, Suction Operatory	EBR	1	Repackager or relabeler	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	1	Repackager or relabeler	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Repackager or relabeler	accessdata.fda.gov
Wire, Orthodontic	DZC	1	Repackager or relabeler	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 29, 2025	K250606	Dental Barrier and Sleeves	PEM	Substantially Equivalent	Yueying Medical Instruments (Langfang) Co., Ltd.	accessdata.fda.gov
February 24, 2025	K241565	Sterilization Package/Reel	FRG	Substantially Equivalent	Anqing Clean Dental Instrument Technology Co., Ltd.	accessdata.fda.gov
December 17, 2024	K241036	Autoclave Indicator Tape; EO Indicator Tape	JOJ	Substantially Equivalent	Jiangmen New Era External Use Drug Co., Ltd.	accessdata.fda.gov
December 5, 2024	K242740	Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)	EIH	Substantially Equivalent	Liaoning Rachcera Material Technology Co., Ltd.	accessdata.fda.gov
May 9, 2024	K233918	Dental Barrier and Sleeves	PEM	Substantially Equivalent	Yongqing Huaguan Dental Instruments Factory	accessdata.fda.gov
September 22, 2023	K220179	High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors	EFB	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.	accessdata.fda.gov
August 24, 2023	K222103	Nitrile Patient Examination Gloves, Powder Free, Pink Color	LZA	Substantially Equivalent	Shandong Yinghng Medical Products Co., Ltd.	accessdata.fda.gov
May 18, 2023	K220829	Endo Motor	EKX	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.	accessdata.fda.gov
March 23, 2023	K222096	Endo Ultrasonic Activator	ELC	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.	accessdata.fda.gov
December 13, 2022	K222651	Surgical Face Mask	FXX	Substantially Equivalent	Xiantao Sanda Industrial Co., Ltd.	accessdata.fda.gov
December 8, 2022	K220826	LED Curing Light	EBZ	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.	accessdata.fda.gov
November 20, 2022	K221165	Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl	LZA	Substantially Equivalent	Sri Trang Gloves (Thailand) Public Company Limited	accessdata.fda.gov
October 12, 2022	K221510	TrusFIL-Flow Flowable Composite Restorative	EBF	Substantially Equivalent	Rizhao Huge Biomaterials Company, Ltd.	accessdata.fda.gov
September 27, 2022	K220831	Dental Implantation Systems, Dental Electrical Motors	EBW	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.	accessdata.fda.gov
September 12, 2022	K221450	Phosphoric Acid Etching Gel	KLE	Substantially Equivalent	Rizhao Huge Biomaterials Company, Ltd.	accessdata.fda.gov
July 20, 2022	K212178	Root Apex Locator	LQY	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.	accessdata.fda.gov
May 26, 2022	K220597	Disposable Surgical Face Mask (FM-34EE,FM-44EE)	FXX	Substantially Equivalent	Qingdao Bestex Rubber & Plastic Products Co., Ltd.	accessdata.fda.gov
January 13, 2022	K203706	Dental Electric Motor	EBW	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
October 14, 2021	K210231	Vittra APS Unique	EBF	Substantially Equivalent	Dentscare Ltda	accessdata.fda.gov
October 7, 2021	K212279	Digital Intraoral X-ray Imaging System	MUH	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
October 6, 2021	K202063	TrusFIL Universal Composite Restorative	EBF	Substantially Equivalent	Rizhao Huge Biomaterials Company, Ltd.	accessdata.fda.gov
September 27, 2021	K212080	Imaging Plate Scanner, i-Scan	MUH	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
May 10, 2021	K203320	Endo Motor	EKX	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
September 25, 2020	K201787	Light Cure Dental Adhesive	KLE	Substantially Equivalent	Rizhao Huge Biomaterials Company, Ltd.	accessdata.fda.gov
September 24, 2020	K201684	A-Silicone for Bite Registration	ELW	Substantially Equivalent	Shandong Huge Dental Material Corporation	accessdata.fda.gov
August 14, 2020	K192682	Orthocem, Ortho Bite	DYH	Substantially Equivalent	Dentscare Ltda	accessdata.fda.gov
August 5, 2020	K201530	Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)	LZA	Substantially Equivalent	Hartalega NGC Sdn. Bhd.	accessdata.fda.gov
April 15, 2020	K193561	Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch	FRG	Substantially Equivalent	Weihai Xingtai Packaging Products Co., Ltd.	accessdata.fda.gov
March 20, 2020	K193581	Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster	LZA	Substantially Equivalent	Sri Trang Gloves (Thailand) Public Company Limited	accessdata.fda.gov
December 13, 2019	K183424	Ambar, Ambar APS, Ambar Universal APS	KLE	Substantially Equivalent	Dentscare Ltda	accessdata.fda.gov
November 2, 2019	K183465	Allcem, Allcem Core	EMA	Substantially Equivalent	Dentscare Ltda	accessdata.fda.gov
July 9, 2019	K181957	Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted	FRG	Substantially Equivalent	Tianchang Jiarui Packaging Material Co., Ltd.	accessdata.fda.gov
May 30, 2019	K182308	Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs	LZA	Substantially Equivalent	Sri Trang Gloves (Thailand) Co., Ltd.	accessdata.fda.gov
December 18, 2018	K181087	Apex Locator, DPEX III	LQY	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
February 22, 2018	K171823	U&U Indicator tape and strip	JOJ	Substantially Equivalent	U&U Medical Technology Co, Ltd.	accessdata.fda.gov
November 8, 2017	K170229	Dental High-speed Turbine Handpiece	EFB	Substantially Equivalent	Guangdong Jinme Medical Technology Co., Ltd.	accessdata.fda.gov
April 28, 2017	K162258	Self Sealing Sterilization Pouches	FRG	Substantially Equivalent	Tianchang Jiarui Packaging Material Co., Ltd.	accessdata.fda.gov
March 8, 2016	K152766	CharmFlex	ELW	Substantially Equivalent	Dentkist, Inc.	accessdata.fda.gov
February 11, 2015	K142685	NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE	LZA	Substantially Equivalent	Siam Sempermed Corp., Ltd.	accessdata.fda.gov
May 28, 2014	K133071	ELASTIC IMPRESSION MATERIAL	ELW	Substantially Equivalent	Rizhao Huge Dental Industry Co., Ltd.	accessdata.fda.gov
February 28, 2013	K123869	POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES	LZA	Substantially Equivalent	Dehai (Shandong) Medical Gloves, Co., Ltd.	accessdata.fda.gov
August 3, 2012	K121526	POWER-FREE NITRILE PATIENT EXAMINATION GLOVES	LZA	Substantially Equivalent	Shandong Junchi Medical Products Co., Ltd.	accessdata.fda.gov
November 18, 2011	K111290	PIEZO BONE SURGERY	DZI	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
September 2, 2010	K101567	SHARPS CONTAINER	MMK	Substantially Equivalent	Cixi Leinuo Plastic Co., Ltd.	accessdata.fda.gov
August 16, 2010	K101029	KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH	ELM	Substantially Equivalent	Huge Dental Material Co., Ltd.	accessdata.fda.gov
March 19, 2008	K080025	LED.L, LED.M, LED.G, LED.B	EBZ	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
December 27, 2007	K071886	SELF SEAL STERILIZATION POUCH	FRG	Substantially Equivalent	Shanghai Jianzhong Medical Packaging Co., Ltd.	accessdata.fda.gov
August 21, 2006	K053555	ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L	ELC	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.	accessdata.fda.gov
June 3, 1999	K990668	POWDER FREE BLUE NITRILE GLOVE	LZA	Substantially Equivalent	Tg Medical Sdn. Bhd.	accessdata.fda.gov
October 15, 1998	K982872	TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)	LYY	Substantially Equivalent	Tg Medical Sdn. Bhd.	accessdata.fda.gov
May 6, 1997	K970794	LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)	LYY	Substantially Equivalent	Siam Sempermed Corp., Ltd.	accessdata.fda.gov
March 16, 1993	K923757	DENTAL DIAMOND DRILLS	DZP	Substantially Equivalent	Alpha Industrializacao DE Metais Ltda.	accessdata.fda.gov

Compare with other makers

Updated May 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.