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FDA 510(k)

MIS Ti-base Abutment

K-Number: K191152 · 2020-07-06

ApplicantDentsply Sirona
Decision Date2020-07-06
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIS Ti-base Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2020-07-06 under 510(k) number K191152. 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 MIS Ti-base Abutment?

MIS Ti-base Abutment is a medical device that received FDA 510(k) clearance on 2020-07-06. The listed applicant is Dentsply Sirona. The 510(k) number is K191152.

When did MIS Ti-base Abutment receive FDA 510(k) clearance?

MIS Ti-base Abutment received FDA 510(k) clearance on 2020-07-06, under 510(k) number K191152.

Who is the listed applicant for MIS Ti-base Abutment?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIS Ti-base Abutment?

The FDA product code for MIS Ti-base Abutment is NHA.

Other records listing Dentsply Sirona as applicant

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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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