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FDA 510(k)

Anatotemp Anatomic Dental Implant Healing Abutment

K-Number: K171922 · 2017-09-28

ApplicantBuckeye Medical Technologies, LLC
Decision Date2017-09-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Anatotemp Anatomic Dental Implant Healing Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Buckeye Medical Technologies, LLC. It received FDA 510(k) clearance on 2017-09-28 under 510(k) number K171922. 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 Anatotemp Anatomic Dental Implant Healing Abutment?

Anatotemp Anatomic Dental Implant Healing Abutment is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Buckeye Medical Technologies, LLC. The 510(k) number is K171922.

When did Anatotemp Anatomic Dental Implant Healing Abutment receive FDA 510(k) clearance?

Anatotemp Anatomic Dental Implant Healing Abutment received FDA 510(k) clearance on 2017-09-28, under 510(k) number K171922.

Who is the listed applicant for Anatotemp Anatomic Dental Implant Healing Abutment?

The FDA 510(k) record lists Buckeye Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anatotemp Anatomic Dental Implant Healing Abutment?

The FDA product code for Anatotemp Anatomic Dental Implant Healing Abutment 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.

NCT07246499Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.COMPLETEDNCT07624331Volumetric Analysis of Peri-Implant Soft Tissue Changes Between Polyethereketone(PEEK) Anatomic Healing Abutments and Standard Healing Abutments in Posterior Single Implant RestorationsRECRUITINGNCT07636265The Effect Of Photobiomodulation On Dental Implant SurvivalCOMPLETEDNCT07687615Cover Screw vs Healing Abutment on OsseointegrationCOMPLETEDNCT07727980Tissue Preservation in Immediate 1C Implants Using an Anatomical Prefabricated Healing AbutmentNOT_YET_RECRUITINGNCT04695899Zirconia Implants for Replacement of a Single ToothACTIVE_NOT_RECRUITING

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.

K253999Universal 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.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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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