Young Dental Manufacturing Co. 1, LLC: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Young Dental Manufacturing Co. 1, LLC” (first 1977, latest 2025), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 351 days, against 158 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 183 |
| 2017 | 0 | — |
| 2018 | 1 | 467 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 351 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 318 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Young Dental Manufacturing Co. 1, LLC took a median 351 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 158 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 2 | 2 |
| KOJ | Airbrush | 2 | 2 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| EHK | Cup, Prophylaxis | 1 | 1 |
| EJE | Frame, Rubber Dam | 1 | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| JEQ | Toothbrush, Powered | 1 | 1 |
Plus 4 more product codes.
Review panels
- Dental (13)
- General Hospital (2)
- General and Plastic Surgery (1)
Most recent Young Dental Manufacturing Co. 1, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241041 | Silver Fluoride Hypersensitivity Varnish | PHR | 2025-02-28 | 318 |
| K201127 | DEFEND Ear-loop Face Masks | FXX | 2021-04-14 | 351 |
| K171377 | Young INFINITY Cordless Handpiece System | EKX | 2018-08-20 | 467 |
| K153334 | Oral-B 5% Sodium Fluoride Varnish | LBH | 2016-05-20 | 183 |
| K932255 | YOUNG D'GRANULATOR | KMW | 1994-04-15 | 340 |
| K903284 | YOUNG PROPHY SYSTEM, PS UNIT | KOJ | 1990-12-17 | 148 |
| K875340 | JETPOLISHER(TM) | KOJ | 1988-06-10 | 163 |
| K875339 | JETPOLISHER AIRPOLISHING POWDER | EJR | 1988-04-18 | 110 |
| K821484 | DAWN LOW SPEED HANDPIECE SYSTEM | EFB | 1982-06-09 | 22 |
| K790723 | PROPHYLAXIS CUPS AND POLISHERS | EHK | 1979-06-15 | 66 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Young Dental Manufacturing Co. 1, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Young Innovations, LLC Dba Plak Smacker (2 510(k)s)
- Young and Moore Enterprises, Inc. (1 510(k)s)
- Young Health Ind. Co., Ltd. (1 510(k)s)
- Young O/S, LLC (1 510(k)s)
- Young OU Brush Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Young Dental Manufacturing Co. 1, LLC?
FDA lists 16 510(k) clearances under the applicant name “Young Dental Manufacturing Co. 1, LLC” (first 1977, latest 2025), across 14 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Young Dental Manufacturing Co. 1, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Young Dental Manufacturing Co. 1, LLC is 88 days. Since 2017: 351 days, versus 158 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Young Dental Manufacturing Co. 1, LLC?
The most frequent FDA product codes under this applicant name are EGS (Handpiece, Contra- And Right-Angle Attachment, Dental, 2); KOJ (Airbrush, 2); EFB (Handpiece, Air-Powered, Dental, 1).
Next steps
- See all 16 Young Dental Manufacturing Co. 1, LLC clearances with predicates and recalls
- Run predicate analysis for product code EGS, Young Dental Manufacturing Co. 1, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.