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FDA 510(k)

METAL-LINED TRANSCEND CERAMIC BRACKET

K-Number: K944286 · 1994-11-29

ApplicantUnitek Corp.
Decision Date1994-11-29
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

METAL-LINED TRANSCEND CERAMIC BRACKET is the device name listed in this FDA 510(k) record. The listed applicant is Unitek Corp.. It received FDA 510(k) clearance on 1994-11-29 under 510(k) number K944286. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METAL-LINED TRANSCEND CERAMIC BRACKET?

METAL-LINED TRANSCEND CERAMIC BRACKET is a medical device that received FDA 510(k) clearance on 1994-11-29. The listed applicant is Unitek Corp.. The 510(k) number is K944286.

When did METAL-LINED TRANSCEND CERAMIC BRACKET receive FDA 510(k) clearance?

METAL-LINED TRANSCEND CERAMIC BRACKET received FDA 510(k) clearance on 1994-11-29, under 510(k) number K944286.

Who is the listed applicant for METAL-LINED TRANSCEND CERAMIC BRACKET?

The FDA 510(k) record lists Unitek Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METAL-LINED TRANSCEND CERAMIC BRACKET?

The FDA product code for METAL-LINED TRANSCEND CERAMIC BRACKET is DYW.

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Other records listing Unitek Corp. 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.

K933501ALASTIKK940165ALASTIKK923999ALASTIK NSK924645TRANSCEND SERIES 6000 DEBONDING INSTRUMENTSK924295DEBRACKETING INSTRUMENTK923432GERMAN MINI DYNALOCK

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Related Devices (Code: DYW)

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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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