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FDA 510(k)

TEETHMATE-F

K-Number: K910424 · 1991-04-03

ApplicantKuraray Co.
Decision Date1991-04-03
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEETHMATE-F is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Co.. It received FDA 510(k) clearance on 1991-04-03 under 510(k) number K910424. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEETHMATE-F?

TEETHMATE-F is a medical device that received FDA 510(k) clearance on 1991-04-03. The listed applicant is Kuraray Co.. The 510(k) number is K910424.

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

TEETHMATE-F received FDA 510(k) clearance on 1991-04-03, under 510(k) number K910424.

Who is the listed applicant for TEETHMATE-F?

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

What is the FDA product code for TEETHMATE-F?

The FDA product code for TEETHMATE-F is EMA.

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Related Devices (Code: EMA)

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

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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