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Data / Medical devices / United States / Young Dental Manufacturing Co 1, LLC.

Young Dental Manufacturing Co 1, LLC.: FDA-registered device maker in Earth City, MO, United States, 20 510(k) clearances

Young Dental Manufacturing Co 1, LLC. is registered with the FDA (registration 1941138) in Earth City, MO, United States. It lists 26 device types. The FDA files 20 510(k) clearances under its listings, the newest dated February 28, 2025. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Young Dental Manufacturing Co 1, LLC.
FDA registration number
1941138
Address
13705 Shoreline Ct E, Earth City, MO, United States, 63045
Owner or operator
Young Innovations Inc (9031933)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
July 29, 1992
Registered through
2027
Brand names listed
Athena 20R E Type Motor, Athena Champion Reusable Prophy Angle, Athena High Speed Handpiece, BRUSHES AND POLISHERS, Biocide G30, Biotrol Prophylaxis Paste, Biotrol Surgical Evacuation Tips, Birex Disinfectant Wipes and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Abutment, Implant, Dental, EndosseousNHA2Contract manufactureraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Contract manufacturer, Manufactureraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Specification developeraccessdata.fda.gov
Cleanser, Root CanalKJJUContract manufactureraccessdata.fda.gov
Condenser, Amalgam And Foil, OperativeEKG1Contract manufactureraccessdata.fda.gov
Cord, RetractionMVLUContract manufactureraccessdata.fda.gov
Cup, ProphylaxisEHK1Manufactureraccessdata.fda.gov
Dental Barriers And SleevesPEM2Repackager or relabeleraccessdata.fda.gov
Diammine Silver Fluoride Dental Hypersensitivity VarnishPHR2Manufactureraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Manufacturer, Specification developeraccessdata.fda.gov
Frame, Rubber DamEJE1Manufactureraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Specification developeraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Pick, MassagingJET1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Plaque Disclosing AgentQJC1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Scaler, UltrasonicELC2Contract manufactureraccessdata.fda.gov
Sterilant, Medical DevicesMED2Repackager or relabeleraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Repackager or relabeleraccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Contract manufactureraccessdata.fda.gov
Varnish, CavityLBH2Complaint file establishment, Contract manufacturer, Manufacturer, Repackager 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
February 28, 2025K241041Silver Fluoride Hypersensitivity VarnishPHRSubstantially EquivalentYoung Dental Manufacturing Co. 1, LLCaccessdata.fda.gov
May 9, 2024K233918Dental Barrier and SleevesPEMSubstantially EquivalentYongqing Huaguan Dental Instruments Factoryaccessdata.fda.gov
August 20, 2018K171377Young INFINITY Cordless Handpiece SystemEKXSubstantially EquivalentYoung Dental Manufacturing Co. 1, LLCaccessdata.fda.gov
May 20, 2016K153334Oral-B 5% Sodium Fluoride VarnishLBHSubstantially EquivalentYoung Dental Manufacturing Co. 1, LLCaccessdata.fda.gov
March 3, 2016K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPEMSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
October 24, 2014K133069CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIESEFBSubstantially EquivalentCodent Technical Industry Co., Ltd.accessdata.fda.gov
July 24, 2008K080814VOCO PROFLUORID VARNISHLBHSubstantially EquivalentVoco GmbHaccessdata.fda.gov
March 20, 2008K073652ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLEEFBSubstantially EquivalentNakamura Magnifier Co., Ltd.accessdata.fda.gov
February 7, 2008K080240CHALLENGER/CLASSIC PUSH BUTTON HANDPIECEEFBSubstantially EquivalentPromident, LLCaccessdata.fda.gov
February 4, 2004K040098VARNISHAMERICALBHSubstantially EquivalentMedical Products Laboratories, Inc.accessdata.fda.gov
March 13, 1998K974670ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTREEFBSubstantially EquivalentAthena Technology, Inc.accessdata.fda.gov
March 11, 1998K974671ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOREFBSubstantially EquivalentAthena Technology, Inc.accessdata.fda.gov
August 10, 1995K914749WAVICIDE(R) -01MEDSubstantially EquivalentWave Energy Systems, Inc.accessdata.fda.gov
December 15, 1994K925678ATHENA HIGH SPEED HANDPIECEEFBSubstantially EquivalentAthena Technology, Inc.accessdata.fda.gov
August 7, 1989K890761STRIP, STERILIZATION INDICATOR; DRY HEATJOJSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
August 7, 1989K890759STRIP, STERILIZATION INDICATOR; STEAMJOJSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
July 25, 1988K881985CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUPEFBSubstantially EquivalentDenticatoraccessdata.fda.gov
June 15, 1979K790722PROPHYLAXIS ANGLEEGSSubstantially EquivalentYoung Dental Manufacturing Co. 1, LLCaccessdata.fda.gov
November 15, 1978K781545AIR POWERED DENTAL HANDPIECEEFBSubstantially EquivalentPromident Mfg., Ltd.accessdata.fda.gov
May 26, 1978K780752PROPHYLAXIS ANGLEEGSSubstantially EquivalentYoung Dental Manufacturing Co. 1, LLCaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 23, 202495302Class IIOngoingBIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.accessdata.fda.gov
May 13, 202494756Class IIOngoingDarby Prophylaxis Paste with 1.23% Fluoride Ion, Mint CoarsePart number 040032, Lot number, 248607 was incorrectly labeled as part number 045032accessdata.fda.gov
October 6, 202393176Class IIOngoingCONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Anglesone lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.accessdata.fda.gov
May 23, 202392401Class IIOngoingBencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnishThe Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.accessdata.fda.gov
December 5, 202291173Class IIIOngoingDenticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714mislabeled productaccessdata.fda.gov
December 29, 202189330Class IIOngoingYOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to moThe Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.accessdata.fda.gov
October 30, 201984249Class IIOngoingOral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.Product shelf life may be shorter than that indicated on the label.accessdata.fda.gov

Compare with other makers

Updated February 28, 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.