Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Young Dental Manufacturing Co. 1, LLC · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
110 daysmedian FDA review time
351 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241041 | Silver Fluoride Hypersensitivity Varnish | Young Dental Manufacturing Co. 1, LLC | 2025-02-28 | 318 | 0 |
| K201127 | DEFEND Ear-loop Face Masks | Young Dental Manufacturing Co. 1, LLC | 2021-04-14 | 351 | 0 |
| K171377 | Young INFINITY Cordless Handpiece System | Young Dental Manufacturing Co. 1, LLC | 2018-08-20 | 467 | 0 |
| K153334 | Oral-B 5% Sodium Fluoride Varnish | Young Dental Manufacturing Co. 1, LLC | 2016-05-20 | 183 | 1 |
| K932255 | YOUNG D'GRANULATOR | Young Dental Manufacturing Co. 1, LLC | 1994-04-15 | 340 | 0 |
| K903284 | YOUNG PROPHY SYSTEM, PS UNIT | Young Dental Manufacturing Co. 1, LLC | 1990-12-17 | 148 | 0 |
| K875340 | JETPOLISHER(TM) | Young Dental Manufacturing Co. 1, LLC | 1988-06-10 | 163 | 0 |
| K875339 | JETPOLISHER AIRPOLISHING POWDER | Young Dental Manufacturing Co. 1, LLC | 1988-04-18 | 110 | 0 |
| K821484 | DAWN LOW SPEED HANDPIECE SYSTEM | Young Dental Manufacturing Co. 1, LLC | 1982-06-09 | 22 | 0 |
| K790723 | PROPHYLAXIS CUPS AND POLISHERS | Young Dental Manufacturing Co. 1, LLC | 1979-06-15 | 66 | 0 |
| K790722 | PROPHYLAXIS ANGLE | Young Dental Manufacturing Co. 1, LLC | 1979-06-15 | 66 | 0 |
| K782104 | PASTE, PRO CARE PROPHYLAXIS | Young Dental Manufacturing Co. 1, LLC | 1979-01-03 | 15 | 0 |
| K781520 | RUBBER DAM HOLDER | Young Dental Manufacturing Co. 1, LLC | 1978-10-10 | 39 | 0 |
| K780929 | COTTON TIPPED POINT | Young Dental Manufacturing Co. 1, LLC | 1978-06-30 | 25 | 0 |
| K780752 | PROPHYLAXIS ANGLE | Young Dental Manufacturing Co. 1, LLC | 1978-05-26 | 18 | 1 |
| K770997 | PRO-CARE | Young Dental Manufacturing Co. 1, LLC | 1977-06-20 | 19 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda