510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040661Substantially Equivalent

Radent Prophy Paste

Pascal International, Inc., Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K040661 is the FDA 510(k) clearance record for RADENT PROPHY PASTE, a class I device, cleared for Pascal Co., Inc. on under FDA product code EJR (Agent, Polishing, Abrasive, Oral Cavity). FDA records list 8 510(k) clearances for Pascal International, Inc., from to . As of , FDA records show no recalls naming K040661.

Clearance record

Decision date
Received
(89 days to decision)
Product code
EJR Agent, Polishing, Abrasive, Oral Cavity
Regulation
21 CFR 872.6030
Device class
Class I
Review panel
Dental
Applicant
Pascal Co., Inc. 2929 NE Northup Way, Bellevue WA
510(k) summary
Statement
Third party review
No

Clearances, product code EJR

Trailing 12 months

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

FDA records show no clearances under product code EJR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJR, 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