510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K033449Substantially Equivalent

Pro-Dentec Double-Pro Prophylaxis Paste with Fluoide Family of Devices

Professional Dental Technologies Therapeutics, Inc., Batesville AR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033449 is the FDA 510(k) clearance record for PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES, a class I device, cleared for Professional Dental Technologies Therapeutics, Inc. on under FDA product code EJR (Agent, Polishing, Abrasive, Oral Cavity). FDA records list one 510(k) clearance for Professional Dental Technologies Therapeutics, Inc. As of , FDA records show no recalls naming K033449.

Clearance record

Decision date
Received
(70 days to decision)
Product code
EJR Agent, Polishing, Abrasive, Oral Cavity
Regulation
21 CFR 872.6030
Device class
Class I
Review panel
Dental
Applicant
Professional Dental Technologies Therapeutics, Inc. 500 White Dr., Batesville AR
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