# K101005: Astra Tech Implant System, New Component

- Pathway: 510(k) (Special)
- Applicant: Astra Tech AB
- Decided: Jun 21, 2011 after 435 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K925765 (1993). 24 ancestors in all.
198 later devices descend from it; 2 cite it directly.
0 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974738: Astra Tech Implant Dental System, Astra Tech, Inc. (1998) Summary page 2.
- K023631: Astra Tech Dental Implants-Ceramic Abutments, Astra Tech, Inc. (2002) Summary page 2.
- K080396: Osseospeed Narrow, Astra Tech AB (2008) Summary page 2.
- K070833: Atlantis Abutment for Astra Implant, Atlantis Components, Inc. (2007) Summary page 2.
- K071946: Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants, Atlantis Components, Inc. (2007) Summary page 2.

## Most influential descendants
- K120414: Osseospeed Plus (2012), 196 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K150295: LOCATOR RTx (2015), 42 descendants of its own
- K191986: DESS Dental Smart Solutions (2019), 38 descendants of its own

## Indications for use
Astra. Tech Implant System abutments are intended to be used in conjunction with the Astra Tech Implant System in fuilly edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. Highly angled abutments on small diameter implants are not recommended for use in the molar region. ZirDesign is not recommended for use in the molar regions.

Source page: https://510kreport.com/device/K101005
Methodology: https://510kreport.com/methodology