510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K081537Substantially Equivalent

Cfs Flexible

Comfort and Flexible Systems, Roswell GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081537 is the FDA 510(k) clearance record for CFS FLEXIBLE, a class II device, cleared for Comfort and Flexible Systems on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list one 510(k) clearance for Comfort and Flexible Systems. As of , FDA records show no recalls naming K081537.

Clearance record

Decision date
Received
(234 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 and Flexible Systems 845 Aronson Lake Ct., Roswell GA
510(k) summary
Summary PDF
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