Company ยท US
Unitek Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1994. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EJF | Bracket, Metal, Orthodontic | 4 |
| EJS | Alloy, Other Noble Metal | 3 |
| JEX | Plier, Orthodontic | 3 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 2 |
| DYW | Bracket, Plastic, Orthodontic | 2 |
| ECI | Band, Elastic, Orthodontic | 2 |
| DYN | Mouthpiece, Saliva Ejector | 1 |
| DYT | Maintainer, Space Preformed, Orthodontic | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 |
| EID | Syringe, Restorative And Impression Material | 1 |
| EJT | Alloy, Gold-Based Noble Metal | 1 |
| EKM | Gutta-Percha | 1 |
| ELR | Post, Root Canal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 29, 1994 | K944286 | METAL-LINED TRANSCEND CERAMIC BRACKET Unitek Corp. | DYW |
| Apr 28, 1994 | K933501 | ALASTIK Unitek Corp. | EJF |
| Mar 7, 1994 | K940165 | ALASTIK Unitek Corp. | ECI |
| Jun 24, 1993 | K923999 | ALASTIK NS Unitek Corp. | ECI |
| Nov 25, 1992 | K924645 | TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS Unitek Corp. | JEX |
| Nov 23, 1992 | K924295 | DEBRACKETING INSTRUMENT Unitek Corp. | JEX |
| Oct 30, 1992 | K923432 | GERMAN MINI DYNALOCK Unitek Corp. | EJF |
| May 29, 1991 | K911271 | ADHESIVE PRECOATED BRACKETS Unitek Corp. | DYH |
| Mar 29, 1991 | K910288 | NONSTAINING ALASTIKS Unitek Corp. | EJF |
| Mar 9, 1989 | K890529 | ALASTIGARD Unitek Corp. | EJF |
| Apr 7, 1988 | K880392 | ORTHOLUX VISIBLE LIGHT CURING UNIT Unitek Corp. | EBZ |
| Mar 31, 1988 | K880393 | TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE Unitek Corp. | DYH |
| Jun 9, 1986 | K861965 | UNITEK CERAMIC BRACKET SYSTEM Unitek Corp. | DYW |
| Apr 29, 1985 | K851386 | UNITEK DISPOSABLE IMPRESSION SYRINGE Unitek Corp. | EID |
| Nov 9, 1984 | K843742 | UNITEK CONVERTIBLE CAP REMOVER TOOL Unitek Corp. | JEX |
| Sep 26, 1983 | K832654 | HEATED GUTTA PERCHA DELIVERY SYSTEM Unitek Corp. | EKM |
| Aug 31, 1983 | K832253 | X-704 Unitek Corp. | EJS |
| Jun 16, 1983 | K831098 | DOMINION Unitek Corp. | EJT |
| Jun 15, 1983 | K831097 | CONCERTO Unitek Corp. | EJS |
| Jun 15, 1983 | K831096 | STROMA II Unitek Corp. | EJS |
| Sep 21, 1981 | K812239 | UNITEK PALATAL BAR Unitek Corp. | DYT |
| Nov 12, 1980 | K802515 | ROOT CANAL POST Unitek Corp. | ELR |
| Feb 6, 1980 | K800210 | TONGUE HOLDER/SALIVA EJECTOR Unitek Corp. | DYN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||