510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K024343Substantially Equivalent

Butler Gum Prophy Paste with Novamin

Usbiomaterials Corp., Alachua FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K024343 is the FDA 510(k) clearance record for BUTLER GUM PROPHY PASTE WITH NOVAMIN, a class I device, cleared for Usbiomaterials Corp. on under FDA product code EJR (Agent, Polishing, Abrasive, Oral Cavity). FDA records list 5 510(k) clearances for Usbiomaterials Corp., from to . As of , FDA records show no recalls naming K024343.

Clearance record

Decision date
Received
(196 days to decision)
Product code
EJR Agent, Polishing, Abrasive, Oral Cavity
Regulation
21 CFR 872.6030
Device class
Class I
Review panel
Dental
Applicant
Usbiomaterials Corp. 13709 Progress Blvd., # 23, Alachua FL
510(k) summary
Summary PDF
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