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FDA 510(k)

FLOSSBRUSH WITH FLUORIDE

K-Number: K964976 · 1997-05-06

Decision Date1997-05-06
Product CodeJES
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLOSSBRUSH WITH FLUORIDE is the device name listed in this FDA 510(k) record. The listed applicant is Flossbrush Interdental Cleaner and Applicator. It received FDA 510(k) clearance on 1997-05-06 under 510(k) number K964976. The device is classified under product code JES. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOSSBRUSH WITH FLUORIDE?

FLOSSBRUSH WITH FLUORIDE is a medical device that received FDA 510(k) clearance on 1997-05-06. The listed applicant is Flossbrush Interdental Cleaner and Applicator. The 510(k) number is K964976.

When did FLOSSBRUSH WITH FLUORIDE receive FDA 510(k) clearance?

FLOSSBRUSH WITH FLUORIDE received FDA 510(k) clearance on 1997-05-06, under 510(k) number K964976.

Who is the listed applicant for FLOSSBRUSH WITH FLUORIDE?

The FDA 510(k) record lists Flossbrush Interdental Cleaner and Applicator as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLOSSBRUSH WITH FLUORIDE?

The FDA product code for FLOSSBRUSH WITH FLUORIDE is JES.

Related Clinical Trials

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.

Related Devices (Code: JES)

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.

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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