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FDA 510(k)

ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT

K-Number: K110356 · 2011-06-10

ApplicantAstra Tech, Inc.
Decision Date2011-06-10
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT is the device name listed in this FDA 510(k) record. The listed applicant is Astra Tech, Inc.. It received FDA 510(k) clearance on 2011-06-10 under 510(k) number K110356. 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 ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT?

ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT is a medical device that received FDA 510(k) clearance on 2011-06-10. The listed applicant is Astra Tech, Inc.. The 510(k) number is K110356.

When did ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT receive FDA 510(k) clearance?

ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT received FDA 510(k) clearance on 2011-06-10, under 510(k) number K110356.

Who is the listed applicant for ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT?

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

What is the FDA product code for ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT?

The FDA product code for ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT 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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