510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K254109Substantially Equivalent

G-Cem Universal

GC America Inc., Alsip IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K254109 is the FDA 510(k) clearance record for G-CEM UNIVERSAL, a class II device, cleared for GC America, Inc. on under FDA product code EMA (Cement, Dental). FDA records list 128 510(k) clearances for GC America, Inc., from to . As of , FDA records show no recalls naming K254109.

Clearance record

Decision date
Received
(150 days to decision)
Product code
EMA Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
GC America, Inc. 3737 W. 127th St., Alsip IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EMA

Trailing 12 months
10 clearances under product code EMA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EMA, trailing twelve months
MonthClearances
November 20250
December 20253
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20261
August 20262
September 20261
October 20260