510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K983357Substantially Equivalent

Mucopren Soft Relining System

Roydent Dental Products, Inc., Rochester Hills MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983357 is the FDA 510(k) clearance record for MUCOPREN SOFT RELINING SYSTEM, a class II device, cleared for Roydent Dental Products, Inc. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 3 510(k) clearances for Roydent Dental Products, Inc., from to . As of , FDA records show no recalls naming K983357.

Clearance record

Decision date
Received
(50 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Roydent Dental Products, Inc. 1010 W. Hamlin Rd., Rochester Hills MI
510(k) summary
Summary
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