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FDA 510(k)

ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS

K-Number: K071946 · 2007-10-05

ApplicantAtlantis Components, Inc.
Decision Date2007-10-05
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Atlantis Components, Inc.. It received FDA 510(k) clearance on 2007-10-05 under 510(k) number K071946. 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, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS?

ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS is a medical device that received FDA 510(k) clearance on 2007-10-05. The listed applicant is Atlantis Components, Inc.. The 510(k) number is K071946.

When did ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS receive FDA 510(k) clearance?

ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS received FDA 510(k) clearance on 2007-10-05, under 510(k) number K071946.

Who is the listed applicant for ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS?

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

What is the FDA product code for ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS?

The FDA product code for ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS is NHA.

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Other records listing Atlantis Components, Inc. as applicant

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.

K103020ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENTK073540ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANTK073258ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENTK072483ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTSK070833ATLANTIS ABUTMENT FOR ASTRA IMPLANTK063734ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE

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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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