510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100539Substantially Equivalent

Preventech Prophylaxis Paste with Fluoride

Preventive Technologies, Inc., Indian Trial NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100539 is the FDA 510(k) clearance record for PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE, a class I device, cleared for Preventive Technologies, Inc. on under FDA product code EJR (Agent, Polishing, Abrasive, Oral Cavity). FDA records list 3 510(k) clearances for Preventive Technologies, Inc., from to . As of , FDA records show no recalls naming K100539.

Clearance record

Decision date
Received
(112 days to decision)
Product code
EJR Agent, Polishing, Abrasive, Oral Cavity
Regulation
21 CFR 872.6030
Device class
Class I
Review panel
Dental
Applicant
Preventive Technologies, Inc. 4330 Mathews-Indian Trl. Rd., Indian Trial NC
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