Food, drugs, devices › Young Dental Manufacturing I, LLC
Device recall: Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
Young Dental Manufacturing I, LLC (Earth City, MO) initiated this device recall on 5 Dec 2022; FDA lists 1 product record under event 91173, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Young Dental Manufacturing I, LLC has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Young Dental Manufacturing I, LLC, Earth City, MO.
Reason for recall
"mislabeled product"
Distribution
"Worldwide distribution - US Nationwide distribution in the states of IA, NY, PA, TN, TX, and the country of Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0725-2023 | Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714 | 600 packs | Class III | Ongoing | 28 Dec 2022 |
Context
Other enforcement events for Young Dental Manufacturing I, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Aug 2024 | BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solut | Device | Class II | 1 |
| 13 May 2024 | Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse | Device | Class II | 1 |
| 6 Oct 2023 | CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles | Device | Class II | 1 |
| 23 May 2023 | BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish | Device | Class II | 1 |
All 5 events for Young Dental Manufacturing I, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "mislabeled product"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution in the states of IA, NY, PA, TN, TX, and the country of Canada."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.