510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K935261Substantially Equivalent

Kooliner II

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

K935261 is the FDA 510(k) clearance record for KOOLINER II, a class II device, cleared for GC America, Inc. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 128 510(k) clearances for GC America, Inc., from to . As of , FDA records show no recalls naming K935261.

Clearance record

Decision date
Received
(84 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
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 EBI

Trailing 12 months
7 clearances under product code EBI in the twelve months to November 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EBI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20263
August 20262
September 20260
October 20260
November 20260