510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Young Dental Manufacturing Co 1, LLC.

Earth City, MO, US

YOUNG DENTAL MANUFACTURING CO 1, LLC. appears in FDA device records in Earth City, MO. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
7
Registered establishments
1

FDA records under these names

3 names

FDA records resolved to Young Dental Manufacturing Co 1, LLC. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Young Dental Manufacturing Co, LLCenforcement report, recall
  • Young Dental Manufacturing I, LLCenforcement report, recall
  • Young Dental Mfg Co I LLCenforcement report, recall

510(k) clearance history

FDA records hold 16 510(k) clearances for Young Dental Manufacturing Co 1, LLC. between 1977 and 2025. The busiest year on record is 1978, with 3. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Young Dental Manufacturing Co 1, LLC., by decision year
YearClearances
19771
19783
19793
19821
19882
19901
19941
20161
20181
20211
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K241041Silver Fluoride Hypersensitivity VarnishPHRSubstantially Equivalent
K201127DEFEND Ear-loop Face MasksFXXSubstantially Equivalent
K171377Young INFINITY Cordless Handpiece SystemEKXSubstantially Equivalent
K153334Oral-B 5% Sodium Fluoride VarnishLBHSubstantially Equivalent
K932255YOUNG D'GRANULATORKMWSubstantially Equivalent
K903284YOUNG PROPHY SYSTEM, PS UNITKOJSubstantially Equivalent
K875340JETPOLISHER(TM)KOJSubstantially Equivalent
K875339JETPOLISHER AIRPOLISHING POWDEREJRSubstantially Equivalent
K821484DAWN LOW SPEED HANDPIECE SYSTEMEFBSubstantially Equivalent
K790723PROPHYLAXIS CUPS AND POLISHERSEHKSubstantially Equivalent
K790722PROPHYLAXIS ANGLEEGSSubstantially Equivalent
K782104PASTE, PRO CARE PROPHYLAXISFZESubstantially Equivalent
K781520RUBBER DAM HOLDEREJESubstantially Equivalent
K780929COTTON TIPPED POINTKXFSubstantially Equivalent
K780752PROPHYLAXIS ANGLEEGSSubstantially Equivalent
K770997PRO-CAREJEQSubstantially Equivalent

Registered establishments

FDA registered establishments for Young Dental Manufacturing Co 1, LLC., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
19411381941138YOUNG DENTAL MANUFACTURING CO 1, LLC.13705 Shoreline Ct E, EARTH CITY, MO 63045 US2026and 16 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0008-2025BIOTROL 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.Class IIOpen, Classified
Z-2143-2024Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint CoarsePart number 040032, Lot number, 248607 was incorrectly labeled as part number 045032Class IIOpen, Classified
Z-0285-2024CONTRA 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.Class IIOpen, Classified
Z-1697-2023BencoDental 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.Class IIOpen, Classified
Z-0725-2023Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714mislabeled productClass IIIOpen, Classified
Z-0555-2022YOUNG 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 monitor one or more parameters of the sterilization process.The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.Class IIOpen, Classified
Z-0661-2020Oral-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.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain