510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121318Substantially Equivalent

Prosoft

Perma Laboratories, Hinckley OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121318 is the FDA 510(k) clearance record for PROSOFT, a class II device, cleared for Perma Laboratories on under FDA product code EBP (Reliner, Denture, Over The Counter). FDA records list one 510(k) clearance for Perma Laboratories. As of , FDA records show no recalls naming K121318.

Clearance record

Decision date
Received
(35 days to decision)
Product code
EBP Reliner, Denture, Over The Counter
Regulation
21 CFR 872.3560
Device class
Class II
Review panel
Dental
Applicant
Perma Laboratories 120 Wakefield Run Blvd., Hinckley OH
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code EBP

Trailing 12 months

FDA records hold no clearances under product code EBP in the trailing twelve months.

FDA records show no clearances under product code EBP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EBP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260