# K230873: Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Aug 1, 2023 after 124 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K925765 (1993). 274 ancestors in all.
No later device cites it as a predicate yet.
0 of 275 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193084: TIB Abutment System, Southern Implants (Pty), Ltd. (2020) Summary page 4.

## Indications for use
The Angulated Screw Channel (ASC) Solution Abutments and SI-BASE Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The ASC Solution Abutments and SI-BASE Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.0 External-Hex implants, Ø3.3 PROVATA implants and Ø3.5/Ø4.0 Deep Conical implants are intended for use with a straight mesostructure component. The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.4 and Ø4.0 External-Hex implants, PROVATA implants and Ø3.5 and Ø4.3 TRI-NEX implants is limited to replacement of maxillary and mandibular lateral and central incisors. The ASC Solution Abutments and SI-BASE Abutments for Compact Conical Abutments are intended for use on straight Compact Conical Abutments with a straight mesostructure component.

Source page: https://510kreport.com/device/K230873
Methodology: https://510kreport.com/methodology