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FDA 510(k)

Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments

K-Number: K230873 · 2023-08-01

ApplicantSouthern Implants (Pty), Ltd.
Decision Date2023-08-01
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

When was Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments approved by the FDA?

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

What company makes Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments?

Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments is manufactured by Southern Implants (Pty), Ltd..

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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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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