# K002513: Astra Tech Implants - Dental System

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Jan 4, 2001 after 142 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
No predicates in its family tree.
426 later devices descend from it; 3 cite it directly.
0 of 427 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K002513
Methodology: https://510kreport.com/methodology