510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K021250Substantially Equivalent

Mk-Dent Push Button Highspeed Handpiece, 4 Holes, Models Hs 2012 (Standard Head) & Hs 2014 (Small Head)

Handpiece Unlimited, Luebeck, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021250 is the FDA 510(k) clearance record for MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD), a class II device, cleared for Handpiece Unlimited on under FDA product code EBF (Material, Tooth Shade, Resin). FDA records list one 510(k) clearance for Handpiece Unlimited. As of , FDA records show no recalls naming K021250.

Clearance record

Decision date
Received
(188 days to decision)
Product code
EBF Material, Tooth Shade, Resin
Regulation
21 CFR 872.3690
Device class
Class II
Review panel
Dental
Applicant
Handpiece Unlimited Katharinenstr. 5, Luebeck, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EBF

Trailing 12 months
19 clearances under product code EBF in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code EBF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20262
April 20265
May 20262
June 20262
July 20262
August 20261
September 20262
October 20260