510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942826Substantially Equivalent

Orthodonitc Metal Reinforced Plastic Bracket

Gac Intl., Inc., Central Islip NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942826 is the FDA 510(k) clearance record for ORTHODONITC METAL REINFORCED PLASTIC BRACKET, a class II device, cleared for Gac Intl., Inc. on under FDA product code DYW (Bracket, Plastic, Orthodontic). FDA records list 13 510(k) clearances for Gac Intl., Inc., from to . As of , FDA records show no recalls naming K942826.

Clearance record

Decision date
Received
(183 days to decision)
Product code
DYW Bracket, Plastic, Orthodontic
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Gac Intl., Inc. 185 Oval Dr., Central Islip NY
510(k) summary
Statement
Third party review
No

Clearances, product code DYW

Trailing 12 months
1 clearance under product code DYW in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DYW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260