510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K910795Substantially Equivalent

Comfor-Dent Denture Liner

Comfort Acrylics, Inc., Vancouver WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910795 is the FDA 510(k) clearance record for COMFOR-DENT DENTURE LINER, a class II device, cleared for Comfort Acrylics Co. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 3 510(k) clearances for Comfort Acrylics Co., from to . As of , FDA records show no recalls naming K910795.

Clearance record

Decision date
Received
(135 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Comfort Acrylics Co. 12716 NE 7th Pl., Vancouver WA
Third party review
No

Clearances, product code EBI

Trailing 12 months
10 clearances under product code EBI in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EBI, trailing twelve months
MonthClearances
November 20253
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20263
August 20262
September 20260
October 20260