510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K903986Substantially Equivalent

Swirl Prophylaxis Paste

Bio-Medica Concepts, West Chester OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903986 is the FDA 510(k) clearance record for SWIRL PROPHYLAXIS PASTE, a class I device, cleared for Bio-Medica Concepts on under FDA product code EJR (Agent, Polishing, Abrasive, Oral Cavity). FDA records list one 510(k) clearance for Bio-Medica Concepts. As of , FDA records show no recalls naming K903986.

Clearance record

Decision date
Received
(211 days to decision)
Product code
EJR Agent, Polishing, Abrasive, Oral Cavity
Regulation
21 CFR 872.6030
Device class
Class I
Review panel
Dental
Applicant
Bio-Medica Concepts 8645 Cincinnati-Columbus Rd.,, West Chester OH
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