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FDA 510(k)

TIB Abutments

K-Number: K222469 · 2023-04-17

ApplicantSouthern Implants (Pty), Ltd.
Decision Date2023-04-17
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TIB Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2023-04-17 under 510(k) number K222469. 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 TIB Abutments?

TIB Abutments is a medical device that received FDA 510(k) clearance on 2023-04-17. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K222469.

When did TIB Abutments receive FDA 510(k) clearance?

TIB Abutments received FDA 510(k) clearance on 2023-04-17, under 510(k) number K222469.

Who is the listed applicant for TIB Abutments?

The FDA 510(k) record lists Southern Implants (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIB Abutments?

The FDA product code for TIB Abutments is NHA.

Other records listing Southern Implants (Pty), Ltd. 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.

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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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