Cleared Traditional

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

K021250 is an FDA 510(k) clearance for MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, manufactured by Handpiece Unlimited. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K021250 · Handpiece Unlimited · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
188d
Days
Class 2
Risk

K021250 is an FDA 510(k) clearance for the MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HE.... Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Handpiece Unlimited (Luebeck, DE). The FDA issued a Cleared decision on October 24, 2002 after a review of 188 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K021250

510(k) Number K021250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2002
Decision Date October 24, 2002
Days to Decision 188 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 128d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 931
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K021250.
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TWINKY STAR
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K021250 · MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)
Download PDF FDA Summary Handpiece Unlimited