Cleared Traditional

K080677 - COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE

K080677 is an FDA 510(k) clearance for COMFORTRONIC 4894 AND COMFORTDRIVE 200X..., manufactured by Kaltenbach & Voigt GmbH & Co.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K080677 · Kaltenbach & Voigt GmbH & Co. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
88d
Days
Class 1
Risk

K080677 is an FDA 510(k) clearance for the COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Kaltenbach & Voigt GmbH & Co. (Orange, US). The FDA issued a Cleared decision on June 6, 2008 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K080677

510(k) Number K080677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2008
Decision Date June 06, 2008
Days to Decision 88 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
40d faster than avg
Panel avg: 128d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 257
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K080677.
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K080677 · COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE
Download PDF FDA Summary Kaltenbach & Voigt Gm…