Not currently registered with FDA under this name
Gac Intl., Inc.
Central Islip, NY, United States. Named as applicant on 13 dental 510(k) clearances between 1977 and 1999. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 131977–1999
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1976–2026
510(k) clearances
Clearances on which FDA names Gac Intl., Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 5 Apr 1999 | K981036 | SMARTBOND | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 14 Dec 1994 | K942826 | ORTHODONITC METAL REINFORCED PLASTIC BRACKET | DYW Orthodontic Plastic Bracket |
| 5 Aug 1994 | K933542 | MESIAL LOOP BAR | ECO Orthodontic Spring |
| 9 May 1994 | K932825 | MICROARCH GOLD BRACKET | EJF Orthodontic Metal Bracket |
| 20 Sep 1993 | K932319 | ORTHODONTIC ELASTOMER | ECI Orthodontic Elastic Band |
| 13 Sep 1993 | K932025 | ION-IMPLANTED NEO SENTALLOY | EJF Orthodontic Metal Bracket |
| 4 Nov 1992 | K920905 | BIOFORCE WIRE | DZC Orthodontic Wire |
| 28 Sep 1992 | K923029 | ORTHODONTIC STAINLESS STEEL BRACKET | EJF Orthodontic Metal Bracket |
| 24 Aug 1992 | K920850 | GAC THUMB-SUCKING CONTROL APPLIANCE | DZC Orthodontic Wire |
| 20 Mar 1992 | K920784 | ORTHODONTIC FACE BOW W/ INNER WIRE | DZB Orthodontic Extraoral Headgear |
| 20 Aug 1985 | K852179 | CERAMIC ORTHODONIT APPLIANCE | EJF Orthodontic Metal Bracket |
| 9 May 1985 | K851055 | SENTINOL -ORTHODONTIC ARCH WIRE | DZC Orthodontic Wire |
| 30 Sep 1977 | K771774 | NEW BASE FOR ORTHODONTIC APPLIANCES | EJF Orthodontic Metal Bracket |
Some of these clearances are listed with FDA today by another company: Dentaurum GmbH & Co. KG (1), Gestenco International AB (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.