Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unitek Corp. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
109 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944286 | METAL-LINED TRANSCEND CERAMIC BRACKET | Unitek Corp. | 1994-11-29 | 88 | 0 |
| K933501 | ALASTIK | Unitek Corp. | 1994-04-28 | 283 | 0 |
| K940165 | ALASTIK | Unitek Corp. | 1994-03-07 | 60 | 0 |
| K923999 | ALASTIK NS | Unitek Corp. | 1993-06-24 | 318 | 0 |
| K924645 | TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS | Unitek Corp. | 1992-11-25 | 72 | 0 |
| K924295 | DEBRACKETING INSTRUMENT | Unitek Corp. | 1992-11-23 | 89 | 0 |
| K923432 | GERMAN MINI DYNALOCK | Unitek Corp. | 1992-10-30 | 109 | 0 |
| K911271 | ADHESIVE PRECOATED BRACKETS | Unitek Corp. | 1991-05-29 | 68 | 0 |
| K910288 | NONSTAINING ALASTIKS | Unitek Corp. | 1991-03-29 | 66 | 0 |
| K890529 | ALASTIGARD | Unitek Corp. | 1989-03-09 | 35 | 0 |
| K880392 | ORTHOLUX VISIBLE LIGHT CURING UNIT | Unitek Corp. | 1988-04-07 | 69 | 0 |
| K880393 | TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE | Unitek Corp. | 1988-03-31 | 62 | 0 |
| K861965 | UNITEK CERAMIC BRACKET SYSTEM | Unitek Corp. | 1986-06-09 | 21 | 0 |
| K851386 | UNITEK DISPOSABLE IMPRESSION SYRINGE | Unitek Corp. | 1985-04-29 | 20 | 0 |
| K843742 | UNITEK CONVERTIBLE CAP REMOVER TOOL | Unitek Corp. | 1984-11-09 | 45 | 0 |
| K832654 | HEATED GUTTA PERCHA DELIVERY SYSTEM | Unitek Corp. | 1983-09-26 | 49 | 0 |
| K832253 | X-704 | Unitek Corp. | 1983-08-31 | 51 | 0 |
| K831098 | DOMINION | Unitek Corp. | 1983-06-16 | 73 | 0 |
| K831096 | STROMA II | Unitek Corp. | 1983-06-15 | 72 | 0 |
| K831097 | CONCERTO | Unitek Corp. | 1983-06-15 | 72 | 0 |
| K812239 | UNITEK PALATAL BAR | Unitek Corp. | 1981-09-21 | 41 | 0 |
| K802515 | ROOT CANAL POST | Unitek Corp. | 1980-11-12 | 28 | 0 |
| K800210 | TONGUE HOLDER/SALIVA EJECTOR | Unitek Corp. | 1980-02-06 | 5 | 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