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FDA 510(k)

BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE

K-Number: K993255 · 1999-12-06

ApplicantColtene/Whaledent, Inc.
Decision Date1999-12-06
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent, Inc.. It received FDA 510(k) clearance on 1999-12-06 under 510(k) number K993255. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE?

BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE is a medical device that received FDA 510(k) clearance on 1999-12-06. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K993255.

When did BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE receive FDA 510(k) clearance?

BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE received FDA 510(k) clearance on 1999-12-06, under 510(k) number K993255.

Who is the listed applicant for BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE?

The FDA 510(k) record lists Coltene/Whaledent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE?

The FDA product code for BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE is FRG.

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Other records listing Coltene/Whaledent, Inc. as applicant

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Related Devices (Code: FRG)

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Official Source

View on FDA Database →

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

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