510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080240Substantially Equivalent

Challenger/classic Push Button Handpiece

Promident, LLC, New City NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K080240 is the FDA 510(k) clearance record for CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE, a class I device, cleared for Promident, LLC on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list 2 510(k) clearances for Promident, LLC, from to . As of , FDA records show no recalls naming K080240.

Clearance record

Decision date
Received
(7 days to decision)
Product code
EFB Handpiece, Air-Powered, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Promident, LLC 242 N. Main St., New City NY
510(k) summary
Statement
Third party review
Yes

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