# K974737: Astra Tech Implant Dental System

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Mar 24, 1998 after 95 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931767 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931767: Astra Tech Implants-Dental System, Astra Tech, Inc. (1994) Summary page 1.
- (no number) Steri-Oss Dental Implants, Impression Coping, Open tray hex transfer, Implant Analog: named in the summary without a submission number

## Indications for use
For use in selected fully edentulous and partially edentulous arches. Replica 3.5: Prosthetic component which can be embedded into a stone cast model which replicates the interior shape and exterior chamber and diameter of a fixture Replica 4.0: Prosthetic component which can be embedded into a stone cast model which replicates the interior shape and exterior chamber and diameter of a fixture Replica ST 4.5: Prosthetic component which can be embedded into a stone cast model which replicates the interior shape and exterior chamber and diameter of a fixture Fixture Transfer - Short: Single unit reseating type impression coping for accurate transfer of fixture location and angulation Fixture Transfer — Long: Single unit reseating type impression coping for accurate transfer of fixture location and angulation Fixture Transfer ST — Short: Two piece pick-up type impression coping for accurate transfer of fixture location and angulation Fixture Transfer ST —Long: Two piece pick-up type impression coping for accurate transfer of fixture location and angulation Fixture Transfer PU — Short: Multi-piece pick-up type impression coping for accurate transfer of fixture location and angulation Fixture Transfer PU - Long: Multi-piece pick-up type impression coping for accurate transfer of fixture location and angulation

Source page: https://510kreport.com/device/K974737
Methodology: https://510kreport.com/methodology