FDA 510(k)

Gekrümmter Schraubkanal (ASC) Lösung Abutments & SI-BASE Abutments

K-Nummer: K230873 · 2023-08-01

AntragstellerSouthern Implants (Pty), Ltd.

Entscheidungsdatum2023-08-01

ProduktcodeNHA

BeratungsausschussDE

EntscheidungSubstantially Equivalent

Produktübersicht

Angulated Screw Channel (ASC) Solution Abutments & SI-BASE 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 2023-08-01 under 510(k) number K230873. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments?

Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments is a medical device that received FDA 510(k) clearance on 2023-08-01. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K230873.

When did Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments receive FDA 510(k) clearance?

Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments received FDA 510(k) clearance on 2023-08-01, under 510(k) number K230873.

Who is the listed applicant for Angulated Screw Channel (ASC) Solution Abutments & SI-BASE 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 Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments?

The FDA product code for Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments is NHA.

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Verwandte Geräte (Code: NHA)

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC 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 AB K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.

Offizielle Quelle

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