510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080677Substantially Equivalent

Comfortronic 4894 and Comfortdrive 200Xda Handpiece

Kaltenbach & Voigt GmbH, Orange CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080677 is the FDA 510(k) clearance record for COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE, a class I device, cleared for Kaltenbach & Voigt GmbH & Co. on under FDA product code EIA (Unit, Operative Dental). FDA records list 11 510(k) clearances for Kaltenbach & Voigt GmbH & Co., from to . As of , FDA records show no recalls naming K080677.

Clearance record

Decision date
Received
(88 days to decision)
Product code
EIA Unit, Operative Dental
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Kaltenbach & Voigt GmbH & Co. 1717 W. Collins, Orange CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EIA

Trailing 12 months
2 clearances under product code EIA in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EIA, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260