# K970073: Bio-Esthetic Indirect Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Steri-Oss, Inc.
- Decided: Jul 3, 1997 after 176 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Friatec's “Frialit-2 MH-6 Abutment”: named in the summary without a submission number

## Indications for use
The intended use of Steri-Oss' Bio-Esthetic indirect Abutment, an abutment retained with a lingual retaining screw, is to provide a stable, secure foundation upon which a prosthetic appliance (the purpose of which is restoration of masticatory function in the edentulous and partially edentulous patient) can be attached, yet remain retrievable.

Source page: https://510kreport.com/device/K970073
Methodology: https://510kreport.com/methodology