# K041492: Astra Tech Implants - Dental System

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Aug 9, 2004 after 66 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 K022562 (2002). 1 ancestor in all.
360 later devices descend from it; 2 cite it directly.
0 of 362 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 2.

## Most influential descendants
- K073075: Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems (2008), 304 descendants of its own
- K083805: Ankylos C/X Dental Implant System (2009), 290 descendants of its own
- K093780: Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment (2010), 200 descendants of its own
- K101004: Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment (2010), 199 descendants of its own
- K120338: Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in Zirconia (2012), 197 descendants of its own

## Indications for use
The Astra Tech Implants - Dental System are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Astra Tech Implants - Dental System are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

Source page: https://510kreport.com/device/K041492
Methodology: https://510kreport.com/methodology