MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)— 510(k) K021250

Name: FDA 510(k) clearance K021250
Creator: U.S. Food and Drug Administration
Published: 2002-10-24

Substantially Equivalent

Handpiece Unlimited

FDA 510(k) clearance K021250 for MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD), Substantially Equivalent on 2002-10-24. Applicant: Handpiece Unlimited. Device class: 2.

Clearance details

Applicant: Handpiece Unlimited
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2002-04-19
Decision date: 2002-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebeck, DE

Download summary PDF View on FDA.gov ↗

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