510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K954012Substantially Equivalent

Disposable Prophy Handpiece

Denticator Intl., Inc., Rancho Cordova CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954012 is the FDA 510(k) clearance record for DISPOSABLE PROPHY HANDPIECE, a class I device, cleared for Denticator Intl., Inc. on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list one 510(k) clearance for Denticator Intl., Inc. As of , FDA records show no recalls naming K954012.

Clearance record

Decision date
Received
(75 days to decision)
Product code
EFB Handpiece, Air-Powered, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Denticator Intl., Inc. 11330 Sunrise Park Dr., #A, Rancho Cordova CA
510(k) summary
Summary
Third party review
No

Clearances, product code EFB

Trailing 12 months
4 clearances under product code EFB in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EFB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20261