Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Millennium Dental Technologies, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
260 daysmedian FDA review time
550 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182930 | PerioLase Nd:YAG Pulsed Dental Laser System | Millennium Dental Technologies, Inc. | 2019-07-12 | 263 | 0 |
| K151763 | PerioLase Nd:YAG Pulsed Dental Laser System | Millennium Dental Technologies, Inc. | 2016-03-15 | 260 | 0 |
| K030290 | PERIOLASE ND:YAG DENTAL LASER SYSTEM | Millennium Dental Technologies, Inc. | 2004-07-26 | 550 | 0 |
| K014272 | PERIOLASE ND:YAG DENTAL LASER SYSTEM | Millennium Dental Technologies, Inc. | 2002-03-27 | 90 | 0 |
| K010771 | PERIOLASE ND:YAG DENTAL LASER SYSTEM | Millennium Dental Technologies, Inc. | 2001-11-27 | 258 | 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