510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K932319Substantially Equivalent

Orthodontic Elastomer

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

K932319 is the FDA 510(k) clearance record for ORTHODONTIC ELASTOMER, a class I device, cleared for Gac Intl., Inc. on under FDA product code ECI (Band, Elastic, Orthodontic). FDA records list 13 510(k) clearances for Gac Intl., Inc., from to . As of , FDA records show no recalls naming K932319.

Clearance record

Decision date
Received
(132 days to decision)
Product code
ECI Band, Elastic, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Gac Intl., Inc. 185 Oval Dr., Central Islip NY
510(k) summary
Statement
Third party review
No

Clearances, product code ECI

Trailing 12 months

FDA records hold no clearances under product code ECI in the trailing twelve months.

FDA records show no clearances under product code ECI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ECI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260