Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Star Dental Mfg. Co. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
26 daysmedian FDA review time
90 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K905155 | HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES | Star Dental Mfg. Co. | 1991-02-13 | 90 | 0 |
| K782007 | ROTARY SCALER | Star Dental Mfg. Co. | 1979-01-03 | 33 | 0 |
| K781281 | CEMENT, DENTAL/CAVITY LINER | Star Dental Mfg. Co. | 1978-08-21 | 26 | 0 |
| K771246 | ALARM SYS FOR NITROUS OXIDE SYS. | Star Dental Mfg. Co. | 1977-07-15 | 4 | 0 |
| K771247 | CORE MATERIAL | Star Dental Mfg. Co. | 1977-07-15 | 4 | 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