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Data / Medical devices / United States / Young Innovations Inc.

Young Innovations Inc.: FDA-registered device maker in Algonquin, IL, United States, 53 510(k) clearances

Young Innovations Inc. is registered with the FDA (registration 2024980) in Algonquin, IL, United States. It lists 88 device types. The FDA files 53 510(k) clearances under its listings, the newest dated April 21, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
2024980
FEI number
3008875470
Address
2260 Wendt St, Algonquin, IL, United States, 60102
Owner or operator
Young Innovations Inc (10028124)
Roles
Complaint file establishment, Repackager or relabeler, Specification developer
First device listed
December 31, 2008
Registered through
2026
Brand names listed
**DISPOSABLE**CK-X-PANDER, 19000 Pro-Matrix Narrow Band, 19001 Pro-Matrix Curve Narrow Band, 19005 Pro-Matrix Wide Band, 19006 Pro-Matrix Curve Wide Band, ACCESSORY, SURGICAL APPAREL- Astek, Accent Brackets, Adhere" Enamel Etch Conditioner and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Repackager or relabeleraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Specification developeraccessdata.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
AirbrushKOJ2Repackager or relabeleraccessdata.fda.gov
Alloy, Other Noble MetalEJS2Repackager or relabeleraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Repackager or relabeleraccessdata.fda.gov
Applicator, ResinKXR1Repackager or relabeleraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Repackager or relabeleraccessdata.fda.gov
Band, Preformed, OrthodonticECM1Repackager or relabeleraccessdata.fda.gov
Bracket, Ceramic, OrthodonticNJM2Repackager or relabeleraccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Repackager or relabeleraccessdata.fda.gov
Bracket, Plastic, OrthodonticDYW2Repackager or relabeleraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Chair, Dental, Without Operative UnitNRU1Repackager or relabeleraccessdata.fda.gov
Clamp, Wire, OrthodonticECN1Repackager or relabeleraccessdata.fda.gov
Cleanser, Root CanalKJJURepackager or relabeleraccessdata.fda.gov
Condenser, Amalgam And Foil, OperativeEKG1Specification developeraccessdata.fda.gov
Cotton, RollEFN1Repackager or relabeleraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Repackager or relabeleraccessdata.fda.gov
Cup, ProphylaxisEHK1Repackager or relabeleraccessdata.fda.gov
Dental Barriers And SleevesPEM2Repackager or relabeleraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Repackager or relabeleraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Repackager or relabeleraccessdata.fda.gov
Disk, AbrasiveEHJ1Repackager or relabeleraccessdata.fda.gov
Drill, Dental, IntraoralDZA1Repackager or relabeleraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Repackager or relabeleraccessdata.fda.gov
Fentanyl And Other Opioid Protection GloveQDO1Repackager or relabeleraccessdata.fda.gov
Film, RadiographicIWZ1Repackager or relabeleraccessdata.fda.gov
Floss, DentalJES1Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Gauze/Sponge, InternalEFQURepackager or relabeleraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Repackager or relabeleraccessdata.fda.gov
General Surgery TrayLRO2Repackager or relabeleraccessdata.fda.gov
Gown, ExaminationFME1Repackager or relabeleraccessdata.fda.gov
Guard, DiskEEJ1Repackager or relabeleraccessdata.fda.gov
Gutta-PerchaEKM1Repackager or relabeleraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Repackager or relabeleraccessdata.fda.gov
Headgear, Extraoral, OrthodonticDZB2Repackager or relabeleraccessdata.fda.gov
Holder, Film, X-RayEGZ1Repackager or relabeleraccessdata.fda.gov
Holder, Head, RadiographicIWY1Repackager or relabeleraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Repackager or relabeleraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Repackager or relabeleraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Latex Patient Examination GloveLYY1Repackager or relabeleraccessdata.fda.gov
Mask, SurgicalFXX2Repackager or relabeler, Specification developeraccessdata.fda.gov
Material, ImpressionELW2Repackager or relabeleraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Repackager or relabeleraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Repackager or relabeleraccessdata.fda.gov
Medical Glove, SpecialtyLZC1Repackager or relabeleraccessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsOPJ1Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Repackager or relabeleraccessdata.fda.gov
Plaque Disclosing AgentQJC1Repackager or relabeleraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Repackager or relabeler, Specification developeraccessdata.fda.gov
Point, AbrasiveEHL1Repackager or relabeleraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeleraccessdata.fda.gov
Post, Root CanalELR1Repackager or relabeleraccessdata.fda.gov
Pusher, Band, OrthodonticECS1Repackager or relabeleraccessdata.fda.gov
Retainer, MatrixJEP1Specification developeraccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Scaler, UltrasonicELC2Repackager or relabeler, Specification developeraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Repackager or relabeleraccessdata.fda.gov
Setter, Band, OrthodonticECR1Repackager or relabeleraccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Complaint file establishmentaccessdata.fda.gov
Spring, OrthodonticECO1Repackager or relabeleraccessdata.fda.gov
Syringe, CartridgeEJI2Specification developeraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Repackager or relabeleraccessdata.fda.gov
System, X-Ray, Extraoral Source, DigitalMUH2Complaint file establishmentaccessdata.fda.gov
Toothbrush, ManualEFW1Repackager or relabeleraccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
Tube, OrthodonticDZD1Repackager or relabeleraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Repackager or relabeleraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Specification developeraccessdata.fda.gov
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-SterileNOB1Repackager or relabeleraccessdata.fda.gov
Unit, X-Ray, Extraoral With TimerEHD2Complaint file establishmentaccessdata.fda.gov
Vinyl Patient Examination GloveLYZ1Repackager or relabeleraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Repackager or relabeleraccessdata.fda.gov
Wire, OrthodonticDZC1Repackager or relabeleraccessdata.fda.gov
Wrap, SterilizationFRG2Repackager or relabeleraccessdata.fda.gov
X-Ray, Tomography, Computed, DentalOAS2Complaint file establishmentaccessdata.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
April 21, 2025K251196Composite Orthodontic Brackets and ButtonsDYWSubstantially EquivalentEc Certification Service GmbHaccessdata.fda.gov
May 9, 2024K233918Dental Barrier and SleevesPEMSubstantially EquivalentYongqing Huaguan Dental Instruments Factoryaccessdata.fda.gov
November 20, 2022K221165Non-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 FentanylLZASubstantially EquivalentSri Trang Gloves (Thailand) Public Company Limitedaccessdata.fda.gov
March 24, 2022K202903Surgical Face MaskFXXSubstantially EquivalentRizhao Sanqi Medical & Health Articles Co., Ltd.accessdata.fda.gov
September 9, 2021K201785EPIEN Dental CleanserKJJSubstantially EquivalentEpien Medical, Inc.accessdata.fda.gov
February 22, 2018K171823U&U Indicator tape and stripJOJSubstantially EquivalentU&U Medical Technology Co, Ltd.accessdata.fda.gov
April 28, 2017K162258Self Sealing Sterilization PouchesFRGSubstantially EquivalentTianchang Jiarui Packaging Material Co., Ltd.accessdata.fda.gov
February 4, 2016K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayOASSubstantially EquivalentPanoramic Corp.accessdata.fda.gov
September 9, 2015K143637U&U Sterilization Pouch and RollFRGSubstantially EquivalentU&U Medical Technology Co, Ltd.accessdata.fda.gov
January 22, 2015K143247Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)LZASubstantially EquivalentCentral Medicare Sdn Bhdaccessdata.fda.gov
July 30, 2014K141130ENCOMPASSMUHSubstantially EquivalentPanoramic Corp.accessdata.fda.gov
February 18, 2014K132953TIDISHEILDPEMSubstantially EquivalentTidi Products,Llcaccessdata.fda.gov
September 28, 2012K121915BRIGHT RESTORATIVE MATERIALSEBFSubstantially EquivalentDmp, Ltd.accessdata.fda.gov
September 12, 2012K112693NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVESLYYSubstantially EquivalentSgmp Co., Ltd.accessdata.fda.gov
March 17, 2011K110371ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAYMUHSubstantially EquivalentPanoramic Corp.accessdata.fda.gov
February 4, 2011K102753TURBO TEMP 3EBGSubstantially EquivalentDanville Materials, Inc.accessdata.fda.gov
January 25, 2011K102561ORTHODONTIC CERAMIC BRACKETNJMSubstantially EquivalentHt Co., Ltd.accessdata.fda.gov
January 13, 2011K102836BONASIL A+ IMPRESSION MATERIALSELWSubstantially EquivalentDmp, Ltd.accessdata.fda.gov
December 3, 2010K102252DMP PIT & FISSURE SEALANTEBCSubstantially EquivalentDmp, Ltd.accessdata.fda.gov
November 23, 2010K102254DMP SINGLE BONDINGKLESubstantially EquivalentDmp, Ltd.accessdata.fda.gov
November 19, 2010K102257NANOCERAM- BRIGHTEBFSubstantially EquivalentDmp, Ltd.accessdata.fda.gov
April 15, 2008K072614MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVELYYSubstantially EquivalentMatang Mfg. Sdn. Bhd.accessdata.fda.gov
March 21, 2008K072406NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)LYYSubstantially EquivalentSgmp Co., Ltd.accessdata.fda.gov
October 12, 2007K071561HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-DEFBSubstantially EquivalentBeijing North Pole Dental Handpiece Co., Ltd.accessdata.fda.gov
June 5, 2006K060347B&L L-BETA, MODEL WL-B1EKRSubstantially EquivalentB&L Biotech Co., Ltd.accessdata.fda.gov
July 20, 2005K051664SCAN300FP / RETROPAN (VDC)MUHSubstantially EquivalentOy Ajat, Ltd.accessdata.fda.gov
January 13, 2005K043557MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMSEHDSubstantially EquivalentPanoramic Corp.accessdata.fda.gov
January 13, 2005K042879NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTINGLZASubstantially EquivalentSgmp Co., Ltd.accessdata.fda.gov
December 1, 2004K042828OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700EKRSubstantially EquivalentYoung O/S, LLCaccessdata.fda.gov
August 14, 2003K032190DISPOSABLE POWDERED VINYL EXAM GLOVESLYZSubstantially EquivalentSynmertex Co, Ltd.accessdata.fda.gov
August 14, 2003K032172DISPOSABLE POWDER FREE VINYL EXAM GLOVESLYZSubstantially EquivalentSynmertex Co, Ltd.accessdata.fda.gov
June 6, 2002K021220NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZASubstantially EquivalentSiam Sempermed Corp., Ltd.accessdata.fda.gov
February 19, 2002K014249JETPOLISHERKOJSubstantially EquivalentDeldent , Ltd.accessdata.fda.gov
January 10, 2002K013969MINIBLASTERKOJSubstantially EquivalentDeldent , Ltd.accessdata.fda.gov
October 24, 2001K012673PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEMDYHSubstantially EquivalentPrime Dental Manufacturing, Inc.accessdata.fda.gov
June 7, 2001K011377NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5LYYSubstantially EquivalentSgmp Co., Ltd.accessdata.fda.gov
June 7, 2001K011370NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROGLYYSubstantially EquivalentSgmp Co., Ltd.accessdata.fda.gov
June 5, 2001K011179DELDENT ULTRASONIC INSERTSELCSubstantially EquivalentDeldent , Ltd.accessdata.fda.gov
November 13, 2000K002521SPARTAN MTSELCSubstantially EquivalentSpartan Marketing Groupaccessdata.fda.gov
July 26, 2000K001619MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)LZASubstantially EquivalentMultisafe Sdn. Bhd.accessdata.fda.gov
June 9, 2000K000358MULTI ADJUSTABLE FACE MASKDZBSubstantially EquivalentOrtho Technologyaccessdata.fda.gov
March 2, 2000K993811MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILELYYSubstantially EquivalentMultisafe Sdn. Bhd.accessdata.fda.gov
November 5, 1998K981064POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVESLZASubstantially EquivalentP.T. Irama Dinamika Latexaccessdata.fda.gov
November 7, 1997K973059PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)LZASubstantially EquivalentSri Johani Sdn. Bhd.accessdata.fda.gov
June 27, 1997K971130DEFEND FLUID RESISTANT PLEATED MASKFXXSubstantially EquivalentCarl Parker Associates, Inc.accessdata.fda.gov
July 10, 1996K961754SAFETY RELEASE MODULEDZBSubstantially EquivalentG & H Wire Co.accessdata.fda.gov
October 3, 1995K953504MICROPRIMEKLESubstantially EquivalentDanville Engineering, Inc.accessdata.fda.gov
February 25, 1994K940120ALPHA-DENTELWSubstantially EquivalentWallace A. Erickson & Co.accessdata.fda.gov
February 2, 1994K936095GAUZE SPONGEEFQSubstantially EquivalentDukal Corp.accessdata.fda.gov
October 23, 1991K914322BARITONE C2 & BARITONE L3EBCSubstantially EquivalentConfi-Dental Products Co.accessdata.fda.gov
August 6, 1990K902075INTRIGUE CERAMIC BRACKETNJMSubstantially EquivalentLancer Orthodontics, Inc.accessdata.fda.gov
August 4, 1988K882436LASER - 1000EHDSubstantially EquivalentPanoramic Corp.accessdata.fda.gov
February 13, 1987K870236PANORAMIC X-RAY MODEL PC-1000EHDSubstantially EquivalentPanoramic Corp.accessdata.fda.gov

Compare with other makers

Updated April 21, 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.