Not currently registered with FDA under this name
Unitek Corp.
Monrovia, CA, United States. Named as applicant on 23 dental 510(k) clearances between 1980 and 1994. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 231980–1994
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 2 markets
Where regulators' registries name Unitek Corp. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Unitek Corp. | 23 clearances | 1980–1994 | Below |
| Australia | TGA | Manufacturer | Unitek Corp | 1 | 2003–2003 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Unitek Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Nov 1994 | K944286 | METAL-LINED TRANSCEND CERAMIC BRACKET | DYW Orthodontic Plastic Bracket |
| 28 Apr 1994 | K933501 | ALASTIK | EJF Orthodontic Metal Bracket |
| 7 Mar 1994 | K940165 | ALASTIK | ECI Orthodontic Elastic Band |
| 24 Jun 1993 | K923999 | ALASTIK NS | ECI Orthodontic Elastic Band |
| 25 Nov 1992 | K924645 | TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS | JEX Orthodontic Plier |
| 23 Nov 1992 | K924295 | DEBRACKETING INSTRUMENT | JEX Orthodontic Plier |
| 30 Oct 1992 | K923432 | GERMAN MINI DYNALOCK | EJF Orthodontic Metal Bracket |
| 29 May 1991 | K911271 | ADHESIVE PRECOATED BRACKETS | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 29 Mar 1991 | K910288 | NONSTAINING ALASTIKS | EJF Orthodontic Metal Bracket |
| 9 Mar 1989 | K890529 | ALASTIGARD | EJF Orthodontic Metal Bracket |
| 7 Apr 1988 | K880392 | ORTHOLUX VISIBLE LIGHT CURING UNIT | EBZ Ultraviolet Activator for Polymerization |
| 31 Mar 1988 | K880393 | TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 9 Jun 1986 | K861965 | UNITEK CERAMIC BRACKET SYSTEM | DYW Orthodontic Plastic Bracket |
| 29 Apr 1985 | K851386 | UNITEK DISPOSABLE IMPRESSION SYRINGE | EID Restorative and Impression Material Syringe |
| 9 Nov 1984 | K843742 | UNITEK CONVERTIBLE CAP REMOVER TOOL | JEX Orthodontic Plier |
| 26 Sep 1983 | K832654 | HEATED GUTTA PERCHA DELIVERY SYSTEM | EKM Gutta-Percha |
| 31 Aug 1983 | K832253 | X-704 | EJS Alloy Other Noble Metal |
| 16 Jun 1983 | K831098 | DOMINION | EJT Gold-Based Noble Metal Alloy |
| 15 Jun 1983 | K831097 | CONCERTO | EJS Alloy Other Noble Metal |
| 15 Jun 1983 | K831096 | STROMA II | EJS Alloy Other Noble Metal |
| 21 Sep 1981 | K812239 | UNITEK PALATAL BAR | DYT Orthodontic Space Preformed Maintainer |
| 12 Nov 1980 | K802515 | ROOT CANAL POST | ELR Root Canal Post |
| 6 Feb 1980 | K800210 | TONGUE HOLDER/SALIVA EJECTOR | DYN Saliva Ejector Mouthpiece |
Some of these clearances are listed with FDA today by another company: Solventum US LLC (3), Five Star Orthodontic Laboratory & Supply, Inc. (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.