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FDA 510(k)

BHDENTAL IMPLANT SYSTEM

K-Number: K103280 · 2011-02-24

ApplicantBhdental, Ltd.
Decision Date2011-02-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BHDENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bhdental, Ltd.. It received FDA 510(k) clearance on 2011-02-24 under 510(k) number K103280. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BHDENTAL IMPLANT SYSTEM?

BHDENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-24. The listed applicant is Bhdental, Ltd.. The 510(k) number is K103280.

When did BHDENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

BHDENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2011-02-24, under 510(k) number K103280.

Who is the listed applicant for BHDENTAL IMPLANT SYSTEM?

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

What is the FDA product code for BHDENTAL IMPLANT SYSTEM?

The FDA product code for BHDENTAL IMPLANT SYSTEM is NHA.

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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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