# K974738: Astra Tech Implant Dental System

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Nov 19, 1998 after 335 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.
543 later devices descend from it; 6 cite it directly.
0 of 545 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 - Esthetic Abutment System: named in the summary without a submission number
- (no number) Steri-Oss Implants Friction Drive Wrench: named in the summary without a submission number
- (no number) Try-In Kit: named in the summary without a submission number

## Most influential descendants
- K024111: Astra Tech Implants-Dental System Fixture Osseospeed (2003), 423 descendants of its own
- K070833: Atlantis Abutment for Astra Implant (2007), 357 descendants of its own
- K081666: Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 Implants (2008), 337 descendants of its own
- K023631: Astra Tech Dental Implants-Ceramic Abutments (2002), 307 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own

## Indications for use
For use in selected fully edentulous and partially edentulous arches. Profile UniAbutment 4.5 22852: Prepable component that is placed in fixture for cemented bridge construction Profile UniAbutment 5.5 22855: Prepable component that is placed in fixture for cemented ultra bridge construction Profile UniAbutment 5.5 22856: Prepable component that is placed in fixture for cemented bridge construction Profile UniAbutment 7.0 22860: Prepable component that is placed in fixture for cemented bridge construction Profile BiAbutment 4.5 22782: Prepable component that is placed in fixture for cemented bridge construction Profile BiAbutment 5.5 22785: Prepable component that is placed in fixture for cemented ultra bridge construction Profile BiAbutment 5.5 22786: Prepable component that is placed in fixture for cemented bridge construction Profile BiAbutment 7.0 22790: Prepable component that is placed in fixture for cemented bridge construction Profile BiAbutment ST 4.5 22870: Prepable component that is placed in fixture for cemented bridge construction Profile BiAbutment ST 5.5 22872: Prepable component that is placed in fixture for cemented bridge construction Profile BiAbutment ST 7.0 22874: Prepable component that is placed in fixture for cemented bridge construction Abutment Screw ST, short 22554: Screw that is used to attach the Profile BiAbutment ST to the fixture

Source page: https://510kreport.com/device/K974738
Methodology: https://510kreport.com/methodology