# K023631: Astra Tech Dental Implants-Ceramic Abutments

- Pathway: 510(k) (Special)
- Applicant: Astra Tech, Inc.
- Decided: Nov 7, 2002 after 9 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: 2 generations back to K931767 (1994). 3 ancestors in all.
307 later devices descend from it; 5 cite it directly.
0 of 311 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 1.
- K991947: 3I Ceramic Abutment System, Implant Innovations, Inc. (1999) Summary page 1.
- (no number) Nobel BioCare Ceradapt: named in the summary without a submission number

## Most influential descendants
- K101005: Astra Tech Implant System, New Component (2011), 198 descendants of its own
- K120414: Osseospeed Plus (2012), 196 descendants of its own
- K081786: Ziocera & Convertible System (2008), 123 descendants of its own
- K100245: HS/HG Prosthetic System (2010), 111 descendants of its own
- K110308: Prosthetic System (2011), 105 descendants of its own

## Indications for use
The Ceramic Abutment is intended for customized prosthetic treatment. The Ceramic Abutment is used with dental implant supported restorations in the anterior] canine, and premolar regions where high esthetic demands are expressed

Source page: https://510kreport.com/device/K023631
Methodology: https://510kreport.com/methodology