Gac Intl., Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Gac Intl., Inc.” (first 1977, latest 1999), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 140 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EJF | Bracket, Metal, Orthodontic | 5 | 5 |
| DZC | Wire, Orthodontic | 3 | 3 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
| DYW | Bracket, Plastic, Orthodontic | 1 | 1 |
| DZB | Headgear, Extraoral, Orthodontic | 1 | 1 |
| ECI | Band, Elastic, Orthodontic | 1 | 1 |
| ECO | Spring, Orthodontic | 1 | 1 |
Review panels
- Dental (13)
Most recent Gac Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981036 | SMARTBOND | DYH | 1999-04-05 | 382 |
| K942826 | ORTHODONITC METAL REINFORCED PLASTIC BRACKET | DYW | 1994-12-14 | 183 |
| K933542 | MESIAL LOOP BAR | ECO | 1994-08-05 | 381 |
| K932825 | MICROARCH GOLD BRACKET | EJF | 1994-05-09 | 334 |
| K932319 | ORTHODONTIC ELASTOMER | ECI | 1993-09-20 | 132 |
| K932025 | ION-IMPLANTED NEO SENTALLOY | EJF | 1993-09-13 | 140 |
| K920905 | BIOFORCE WIRE | DZC | 1992-11-04 | 251 |
| K923029 | ORTHODONTIC STAINLESS STEEL BRACKET | EJF | 1992-09-28 | 97 |
| K920850 | GAC THUMB-SUCKING CONTROL APPLIANCE | DZC | 1992-08-24 | 181 |
| K920784 | ORTHODONTIC FACE BOW W/ INNER WIRE | DZB | 1992-03-20 | 29 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gac Intl., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Gac Intl., Inc.?
FDA lists 13 510(k) clearances under the applicant name “Gac Intl., Inc.” (first 1977, latest 1999), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gac Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gac Intl., Inc. is 140 days.
Which FDA product codes appear under Gac Intl., Inc.?
The most frequent FDA product codes under this applicant name are EJF (Bracket, Metal, Orthodontic, 5); DZC (Wire, Orthodontic, 3); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 1).
Next steps
- See all 13 Gac Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJF, Gac Intl., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.