Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT

K-Number: K073540 · 2008-02-29

ApplicantAtlantis Components, Inc.
Decision Date2008-02-29
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT 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 2008-02-29 under 510(k) number K073540. 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 IN ZIRCONIA FOR BIOHORIZONS IMPLANT?

ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT is a medical device that received FDA 510(k) clearance on 2008-02-29. The listed applicant is Atlantis Components, Inc.. The 510(k) number is K073540.

When did ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT receive FDA 510(k) clearance?

ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT received FDA 510(k) clearance on 2008-02-29, under 510(k) number K073540.

Who is the listed applicant for ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT?

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 IN ZIRCONIA FOR BIOHORIZONS IMPLANT?

The FDA product code for ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT is NHA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 ABUTMENTK073258ATLANTIS 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 IMPLANTK063734ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE

View all 18 devices →

Related Devices (Code: NHA)

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.

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.

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.

↑