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FDA 510(k)

BRUXTRAK MATERIAL

K-Number: K974160 · 1998-03-11

ApplicantBruxcare, LLC
Decision Date1998-03-11
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRUXTRAK MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Bruxcare, LLC. It received FDA 510(k) clearance on 1998-03-11 under 510(k) number K974160. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRUXTRAK MATERIAL?

BRUXTRAK MATERIAL is a medical device that received FDA 510(k) clearance on 1998-03-11. The listed applicant is Bruxcare, LLC. The 510(k) number is K974160.

When did BRUXTRAK MATERIAL receive FDA 510(k) clearance?

BRUXTRAK MATERIAL received FDA 510(k) clearance on 1998-03-11, under 510(k) number K974160.

Who is the listed applicant for BRUXTRAK MATERIAL?

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

What is the FDA product code for BRUXTRAK MATERIAL?

The FDA product code for BRUXTRAK MATERIAL is EBI.

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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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