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FDA 510(k)

COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE

K-Number: K080677 · 2008-06-06

ApplicantKaltenbach & Voigt GmbH & Co.
Decision Date2008-06-06
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Kaltenbach & Voigt GmbH & Co.. It received FDA 510(k) clearance on 2008-06-06 under 510(k) number K080677. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE?

COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE is a medical device that received FDA 510(k) clearance on 2008-06-06. The listed applicant is Kaltenbach & Voigt GmbH & Co.. The 510(k) number is K080677.

When did COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE receive FDA 510(k) clearance?

COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE received FDA 510(k) clearance on 2008-06-06, under 510(k) number K080677.

Who is the listed applicant for COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE?

The FDA 510(k) record lists Kaltenbach & Voigt GmbH & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE?

The FDA product code for COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE is EIA.

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Other records listing Kaltenbach & Voigt GmbH & Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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