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FDA 510(k)

ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT

K-Number: K062197 · 2007-02-28

ApplicantAtlantis Components, Inc.
Decision Date2007-02-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT 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 2007-02-28 under 510(k) number K062197. 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 ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT?

ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT is a medical device that received FDA 510(k) clearance on 2007-02-28. The listed applicant is Atlantis Components, Inc.. The 510(k) number is K062197.

When did ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT receive FDA 510(k) clearance?

ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT received FDA 510(k) clearance on 2007-02-28, under 510(k) number K062197.

Who is the listed applicant for ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT?

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 ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT?

The FDA product code for ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT is NHA.

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Other records listing Atlantis Components, Inc. as applicant

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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 IMPLANTSK071946ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTSK070833ATLANTIS ABUTMENT FOR ASTRA IMPLANT

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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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