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Data / Medical devices / United States / 3D Dental Desings And Development

3D Dental Desings And Development: FDA-registered device maker in Shaker Heights, OH, United States, 39 510(k) clearances

3D Dental Desings And Development is registered with the FDA (registration 3010864832) in Shaker Heights, OH, United States. It lists 92 device types. The FDA files 39 510(k) clearances under its listings, the newest dated July 6, 2020. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch 3D Dental Desings And Development
FDA registration number
3010864832
FEI number
3010862763
Address
16781 chagrin blvd suite 434, Shaker Heights, OH, United States, 44120
Owner or operator
3D Dental Designs and Development LLC (10046685)
Roles
Contract manufacturer, Repackager or relabeler
First device listed
April 28, 2014
Registered through
2026
Brand names listed
JOY Smart Matrix Bands

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Repackager or relabeleraccessdata.fda.gov
Accessories, Cleaning Brushes, For EndoscopeMNL1Repackager or relabeleraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Repackager or relabeleraccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Repackager or relabeleraccessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, ResinDYH2Repackager or relabeleraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Repackager or relabeleraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Repackager or relabeleraccessdata.fda.gov
Alloy, AmalgamEJJ2Repackager or relabeleraccessdata.fda.gov
Amalgamator, Dental, Ac-PoweredEFD1Repackager or relabeleraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Repackager or relabeleraccessdata.fda.gov
Applicator, ResinKXR1Repackager or relabeleraccessdata.fda.gov
Apron, ProtectiveIWO1Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Repackager or relabeleraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Broach, EndodonticEKW1Repackager or relabeleraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Cement, DentalEMA2Repackager or relabeleraccessdata.fda.gov
Chair, Dental, Without Operative UnitNRU1Repackager or relabeleraccessdata.fda.gov
Cleanser, Root CanalKJJURepackager or relabeleraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Repackager or relabeleraccessdata.fda.gov
Cotton, RollEFN1Repackager or relabeleraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Repackager or relabeleraccessdata.fda.gov
Crown, PreformedELZ1Repackager or relabeleraccessdata.fda.gov
Cup, ProphylaxisEHK1Repackager or relabeleraccessdata.fda.gov
Denture, Plastic, TeethELM2Repackager or relabeleraccessdata.fda.gov
Device, Digital Image Storage, RadiologicalLMB1Repackager or relabeleraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Repackager or relabeleraccessdata.fda.gov
Dispenser, Solid MedicationNXB1Repackager or relabeleraccessdata.fda.gov
Dress, SurgicalFYE1Repackager or relabeleraccessdata.fda.gov
Drill, Dental, IntraoralDZA1Repackager or relabeleraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Repackager or relabeleraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Repackager or relabeleraccessdata.fda.gov
Film, RadiographicIWZ1Repackager or relabeleraccessdata.fda.gov
Floss, DentalJES1Repackager or relabeleraccessdata.fda.gov
Gag, MouthKBN1Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Gutta-PerchaEKM1Repackager or relabeleraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Repackager or relabeleraccessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other BiologicsQSYURepackager or relabeleraccessdata.fda.gov
Holder, Film, X-RayEGZ1Repackager or relabeleraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Repackager or relabeleraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Knife, Margin Finishing, OperativeEJZ1Repackager or relabeleraccessdata.fda.gov
Latex Patient Examination GloveLYY1Repackager or relabeleraccessdata.fda.gov
Locator, Root ApexLQYURepackager or relabeleraccessdata.fda.gov
Mask, ScavengingKHA1Repackager or relabeleraccessdata.fda.gov
Mask, SurgicalFXX2Repackager or relabeleraccessdata.fda.gov
Material, ImpressionELW2Repackager or relabeleraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Repackager or relabeleraccessdata.fda.gov
Medical Glove, SpecialtyLZC1Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Repackager or relabeleraccessdata.fda.gov
Needle, DentalDZM1Contract manufactureraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Repackager or relabeleraccessdata.fda.gov
Non-Surgical GownOEA1Repackager or relabeleraccessdata.fda.gov
Oral Wound DressingOLRURepackager or relabeleraccessdata.fda.gov
Pick, MassagingJET1Repackager or relabeleraccessdata.fda.gov
Point, Paper, EndodonticEKN1Repackager or relabeleraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeleraccessdata.fda.gov
Post, Root CanalELR1Repackager or relabeleraccessdata.fda.gov
Respirator, SurgicalMSH2Repackager or relabeleraccessdata.fda.gov
Retainer, MatrixJEP1Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Scaler, UltrasonicELC2Repackager or relabeleraccessdata.fda.gov
Screen, Intensifying, RadiographicEAM1Repackager or relabeleraccessdata.fda.gov
Spreader, Pulp Canal Filling Material, EndodonticEKK1Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, NaturalGAL2Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Repackager or relabeleraccessdata.fda.gov
Suture, Surgical, Absorbable, PolydioxanoneNEW2Repackager or relabeleraccessdata.fda.gov
Syringe, AntistickMEG2Repackager or relabeleraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Repackager or relabeleraccessdata.fda.gov
Syringe, PistonFMF2Repackager or relabeleraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Repackager or relabeleraccessdata.fda.gov
Tester, PulpEAT2Repackager or relabeleraccessdata.fda.gov
Toothbrush, ManualEFW1Repackager or relabeleraccessdata.fda.gov
Toothbrush, PoweredJEQ1Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Repackager or relabeleraccessdata.fda.gov
Tray, SurgicalLRP1Repackager or relabeleraccessdata.fda.gov
Tube Impression And MatrixKCQ1Repackager or relabeleraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Repackager or relabeleraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Repackager or relabeleraccessdata.fda.gov
Varnish, CavityLBH2Repackager or relabeleraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Repackager or relabeleraccessdata.fda.gov
Wrap, SterilizationFRG2Repackager or relabeleraccessdata.fda.gov
Zinc Oxide EugenolEMB1Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 6, 2020K200330RC-Prime Root Canal Preparation CreamKJJSubstantially EquivalentPac-Dent, Inc.accessdata.fda.gov
September 6, 2019K183665Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single UseMEGSubstantially EquivalentJiangsu Micsafe Medical Technology Co., Ltd.accessdata.fda.gov
December 18, 2018K181087Apex Locator, DPEX IIILQYSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
January 25, 2018K173062Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))FXXSubstantially EquivalentV&Q Manufacturing Corporationaccessdata.fda.gov
January 24, 2018K173196SUNTOUCH Dental DressingOLRSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
August 4, 2016K152471CAPO BULK FILLEBFSubstantially EquivalentSchuetz Dental GmbHaccessdata.fda.gov
September 9, 2015K143637U&U Sterilization Pouch and RollFRGSubstantially EquivalentU&U Medical Technology Co, Ltd.accessdata.fda.gov
June 23, 2015K150696Jade 37% Phosphoric Acid Etchant GelKLESubstantially EquivalentDharma Research, Inc.accessdata.fda.gov
November 14, 2014K142810WEGO-PGCL Absorbable Surgical Monofilament SutureGAMSubstantially EquivalentFoosin Medical Supplies Inc., Ltd.accessdata.fda.gov
July 3, 2014K133689POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINKLZASubstantially EquivalentPt. Medisafe Technologiesaccessdata.fda.gov
May 23, 2012K112800SUNTOUCH TOPICAL HEMOSTATIC DRESSINGQSYSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
February 7, 2012K112591SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORSFRGSubstantially EquivalentSafe Secure Packaging Co., Ltd.accessdata.fda.gov
December 14, 2011K112057KDL SYRINGES AND NEEDLEFMFSubstantially EquivalentShanghai Kindly Enterprise Dev. Group Co.,accessdata.fda.gov
February 4, 2011K102753TURBO TEMP 3EBGSubstantially EquivalentDanville Materials, Inc.accessdata.fda.gov
September 9, 2010K101551PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-MEFBSubstantially EquivalentDelma Medical Instrument (Guangzhou) Co., Ltd.accessdata.fda.gov
March 5, 2009K083755NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGSLZASubstantially EquivalentSiam Sempermed Corp., Ltd.accessdata.fda.gov
June 9, 2008K080684WG-SURGICAL SUTURES WITH NEEDLEGAPSubstantially EquivalentFoosin Medical Supplies, Inc.accessdata.fda.gov
April 30, 2008K073614WG-SURGICAL SUTURES WITH NEEDLENEWSubstantially EquivalentFoosin Medical Supplies, Inc.accessdata.fda.gov
March 19, 2008K080025LED.L, LED.M, LED.G, LED.BEBZSubstantially EquivalentGuilin Woodpecker Medical Instrument Co., Ltd.accessdata.fda.gov
December 27, 2007K071886SELF SEAL STERILIZATION POUCHFRGSubstantially EquivalentShanghai Jianzhong Medical Packaging Co., Ltd.accessdata.fda.gov
October 4, 2007K071740CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVESLZASubstantially EquivalentMedtexx Manufacturing Sdn. Bhd.accessdata.fda.gov
April 22, 2004K040396ULTRASONIC SCALER ELEGANCE MS-10 (25K)ELCSubstantially EquivalentRolence Enteprise, Inc.accessdata.fda.gov
February 4, 2004K040098VARNISHAMERICALBHSubstantially EquivalentMedical Products Laboratories, Inc.accessdata.fda.gov
June 12, 2002K020874ULTRA-LITE 5 TURBO LIGHT CURE UNITEBZSubstantially EquivalentRolence Ent., Inc.accessdata.fda.gov
February 19, 2002K013970PRIME-DENT HEMA DESENSITIZEREBFSubstantially EquivalentPrime Dental Manufacturing, Inc.accessdata.fda.gov
October 24, 2001K012673PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEMDYHSubstantially EquivalentPrime Dental Manufacturing, Inc.accessdata.fda.gov
September 4, 2001K011785NOVEL PRINT CYAN ALGINATESELWSubstantially EquivalentManufacturera Dental Continentalaccessdata.fda.gov
May 30, 2000K001108PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIALEBFSubstantially EquivalentPrime Dental Manufacturing, Inc.accessdata.fda.gov
April 28, 2000K000542PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USPGALSubstantially EquivalentArc Medical Supplies (Beijing) Co, Ltd.accessdata.fda.gov
April 28, 2000K000541SILK NONABSORBABLE SURGICAL SUTURES, USPGAPSubstantially EquivalentArc Medical Supplies (Beijing) Co, Ltd.accessdata.fda.gov
January 31, 2000K994224PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIALEBFSubstantially EquivalentPrime Dental Manufacturing, Inc.accessdata.fda.gov
February 12, 1999K982915SCI-PHARM DFV VARNISHLBHSubstantially EquivalentScientific Pharmaceuticals, Inc.accessdata.fda.gov
November 5, 1998K981064POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVESLZASubstantially EquivalentP.T. Irama Dinamika Latexaccessdata.fda.gov
May 6, 1997K970794LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)LYYSubstantially EquivalentSiam Sempermed Corp., Ltd.accessdata.fda.gov
November 1, 1993K933543ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)EMASubstantially EquivalentJedental Co., Inc.accessdata.fda.gov
August 22, 1990K895910STEAMLINEJOJSubstantially EquivalentPropper Mfg. Co., Inc.accessdata.fda.gov
December 30, 1980K802989MEISINGER TUNGSTEN CARBIDE & STEEL DT.B.EJLSubstantially EquivalentSwiss American Metal Craft Corp.accessdata.fda.gov
July 8, 1980K801380CROWN DELTA SILICONE IMPRESSION MATERIALELWSubstantially EquivalentCrown Delta Corp.accessdata.fda.gov
November 15, 1976K760980DENTAL ALLOYEJJSubstantially EquivalentAdp Intl., Inc.accessdata.fda.gov

Compare with other makers

Updated July 6, 2020. 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.