Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alpine Dental Equipment Co. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
115 daysmedian FDA review time
232 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880474 | AREA (DENTAL CHAIR) | Alpine Dental Equipment Co. | 1988-09-23 | 232 | 0 |
| K880475 | SKEMA (DENTAL UNIT) | Alpine Dental Equipment Co. | 1988-09-23 | 232 | 0 |
| K854647 | POLO DENTAL UNIT | Alpine Dental Equipment Co. | 1986-06-05 | 198 | 0 |
| K854643 | SOLAR | Alpine Dental Equipment Co. | 1986-03-14 | 115 | 0 |
| K854642 | SOLAR CART | Alpine Dental Equipment Co. | 1986-03-14 | 115 | 0 |
| K854645 | GOLD AIR, GOLD LIGHT | Alpine Dental Equipment Co. | 1986-03-12 | 113 | 0 |
| K854641 | SOLAR F | Alpine Dental Equipment Co. | 1986-03-10 | 111 | 0 |
| K854646 | VEGA DENTAL OPERATING LIGHT | Alpine Dental Equipment Co. | 1986-03-06 | 107 | 0 |
| K854741 | X-RANGE 65 | Alpine Dental Equipment Co. | 1986-03-06 | 101 | 0 |
| K854644 | MANTA DENTAL CHAIR | Alpine Dental Equipment Co. | 1986-01-23 | 65 | 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