Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Dental Technologies, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
342 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023547 | DIOLASE 980 D LASER SYSTEM | American Dental Technologies, Inc. | 2003-04-15 | 176 | 0 |
| K012127 | PULSEMASTER ERBIUM DENTAL LASER SYSTEM | American Dental Technologies, Inc. | 2001-10-04 | 87 | 0 |
| K012213 | GULLIVER AND CLASSE A | American Dental Technologies, Inc. | 2001-08-13 | 28 | 0 |
| K984486 | PULSEMASTER DENTAL LASER SYSTEM | American Dental Technologies, Inc. | 1999-05-13 | 147 | 0 |
| K972325 | PULSEMASTER 1000 ST DENTAL LASER SYSTEM | American Dental Technologies, Inc. | 1997-09-19 | 88 | 0 |
| K961269 | PULSEMASTER | American Dental Technologies, Inc. | 1997-03-10 | 342 | 0 |
| K961136 | PULSEMASTER | American Dental Technologies, Inc. | 1996-06-03 | 74 | 0 |
| K952333 | PLASMA ARC CURING SYSTEM | American Dental Technologies, Inc. | 1995-08-10 | 84 | 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