510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K052462Substantially Equivalent

G-Coat

GC America Inc., Alsip IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K052462 is the FDA 510(k) clearance record for G-COAT, a class II device, cleared for GC America, Inc. on under FDA product code EBD (Coating, Filling Material, Resin). FDA records list 128 510(k) clearances for GC America, Inc., from to . As of , FDA records show no recalls naming K052462.

Clearance record

Decision date
Received
(42 days to decision)
Product code
EBD Coating, Filling Material, Resin
Regulation
21 CFR 872.3310
Device class
Class II
Review panel
Dental
Applicant
GC America, Inc. 3737 W. 127th St., Alsip IL
510(k) summary
Statement
Third party review
No

Clearances, product code EBD

Trailing 12 months
1 clearance under product code EBD in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260