# K980698: Astra Tech Implants - Dental System

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Mar 19, 1998 after 24 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.
424 later devices descend from it; 2 cite it directly.
0 of 426 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 REPLACE Direct Abutment 5.0 Series: 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
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K060958: Straumann Narrow Neck Implants (2006), 228 descendants of its own

## Indications for use
For use in cement retained crown and bridge construction. Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin. Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin. Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin. Attachment element for connection/fixation of abutments to fixtures Attachment element for connection/fixation of abutments to fixtures

Source page: https://510kreport.com/device/K980698
Methodology: https://510kreport.com/methodology