510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K954281Substantially Equivalent

Panasil Impression Material

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

K954281 is the FDA 510(k) clearance record for PANASIL IMPRESSION MATERIAL, a class II device, cleared for Roydent Dental Products, Inc. on under FDA product code ELW (Material, Impression). FDA records list 3 510(k) clearances for Roydent Dental Products, Inc., from to . As of , FDA records show no recalls naming K954281.

Clearance record

Decision date
Received
(285 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
Roydent Dental Products, Inc. 1010 W. Hamlin Rd., Rochester Hills MI
510(k) summary
Statement
Third party review
No

Clearances, product code ELW

Trailing 12 months
3 clearances under product code ELW in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ELW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20262
October 20260