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FDA 510(k)

ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW

K-Number: K981858 · 1999-03-22

ApplicantAtlantis Components, Inc.
Decision Date1999-03-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW 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 1999-03-22 under 510(k) number K981858. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW?

ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW is a medical device that received FDA 510(k) clearance on 1999-03-22. The listed applicant is Atlantis Components, Inc.. The 510(k) number is K981858.

When did ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW receive FDA 510(k) clearance?

ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW received FDA 510(k) clearance on 1999-03-22, under 510(k) number K981858.

Who is the listed applicant for ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW?

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 AND ATLANTIS ABUTMENT SCREW?

The FDA product code for ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW is DZE.

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

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Related Devices (Code: DZE)

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.

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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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