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FDA 510(k)

TEETHMATE F-1

K-Number: K012742 · 2001-09-14

ApplicantKuraray Medical, Inc.
Decision Date2001-09-14
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEETHMATE F-1 is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Medical, Inc.. It received FDA 510(k) clearance on 2001-09-14 under 510(k) number K012742. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEETHMATE F-1?

TEETHMATE F-1 is a medical device that received FDA 510(k) clearance on 2001-09-14. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K012742.

When did TEETHMATE F-1 receive FDA 510(k) clearance?

TEETHMATE F-1 received FDA 510(k) clearance on 2001-09-14, under 510(k) number K012742.

Who is the listed applicant for TEETHMATE F-1?

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

What is the FDA product code for TEETHMATE F-1?

The FDA product code for TEETHMATE F-1 is EBC.

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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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