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FDA 510(k)

PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02

K-Number: K070127 · 2007-03-29

ApplicantKevin Vu, Dds
Decision Date2007-03-29
Product CodeEMN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 is the device name listed in this FDA 510(k) record. The listed applicant is Kevin Vu, Dds. It received FDA 510(k) clearance on 2007-03-29 under 510(k) number K070127. The device is classified under product code EMN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02?

PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 is a medical device that received FDA 510(k) clearance on 2007-03-29. The listed applicant is Kevin Vu, Dds. The 510(k) number is K070127.

When did PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 receive FDA 510(k) clearance?

PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 received FDA 510(k) clearance on 2007-03-29, under 510(k) number K070127.

Who is the listed applicant for PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02?

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

What is the FDA product code for PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02?

The FDA product code for PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 is EMN.

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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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