510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K981869Substantially Equivalent

Pro-Flex Disposable Prophy Angle

Professional Dental Mfg., Inc., Batesville AR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981869 is the FDA 510(k) clearance record for PRO-FLEX DISPOSABLE PROPHY ANGLE, a class I device, cleared for Professional Dental Mfg., Inc. on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list 2 510(k) clearances for Professional Dental Mfg., Inc., from to . As of , FDA records show no recalls naming K981869.

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
Professional Dental Mfg., Inc. 633 Lawrence St., Batesville AR
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