510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881974Substantially Equivalent

Proficient(tm) Prophylaxis Angle

Block Drug Company, Inc., Jersey City NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881974 is the FDA 510(k) clearance record for PROFICIENT(TM) PROPHYLAXIS ANGLE, a class I device, cleared for Block Drug Company, Inc. on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list 10 510(k) clearances for Block Drug Company, Inc., from to . As of , FDA records show no recalls naming K881974.

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
Block Drug Company, Inc. 257 Cornelison Ave., Jersey City NJ
Third party review
No

Clearances, product code EFB

Trailing 12 months
3 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 20260