Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gac Intl., Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
381 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981036 | SMARTBOND | Gac Intl., Inc. | 1999-04-05 | 382 | 0 |
| K942826 | ORTHODONITC METAL REINFORCED PLASTIC BRACKET | Gac Intl., Inc. | 1994-12-14 | 183 | 0 |
| K933542 | MESIAL LOOP BAR | Gac Intl., Inc. | 1994-08-05 | 381 | 0 |
| K932825 | MICROARCH GOLD BRACKET | Gac Intl., Inc. | 1994-05-09 | 334 | 0 |
| K932319 | ORTHODONTIC ELASTOMER | Gac Intl., Inc. | 1993-09-20 | 132 | 0 |
| K932025 | ION-IMPLANTED NEO SENTALLOY | Gac Intl., Inc. | 1993-09-13 | 140 | 0 |
| K920905 | BIOFORCE WIRE | Gac Intl., Inc. | 1992-11-04 | 251 | 0 |
| K923029 | ORTHODONTIC STAINLESS STEEL BRACKET | Gac Intl., Inc. | 1992-09-28 | 97 | 0 |
| K920850 | GAC THUMB-SUCKING CONTROL APPLIANCE | Gac Intl., Inc. | 1992-08-24 | 181 | 0 |
| K920784 | ORTHODONTIC FACE BOW W/ INNER WIRE | Gac Intl., Inc. | 1992-03-20 | 29 | 0 |
| K852179 | CERAMIC ORTHODONIT APPLIANCE | Gac Intl., Inc. | 1985-08-20 | 92 | 0 |
| K851055 | SENTINOL -ORTHODONTIC ARCH WIRE | Gac Intl., Inc. | 1985-05-09 | 56 | 0 |
| K771774 | NEW BASE FOR ORTHODONTIC APPLIANCES | Gac Intl., Inc. | 1977-09-30 | 11 | 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