# K032448: Altatec Ceramic Abutment

- Pathway: 510(k) (Special)
- Applicant: Altatec Biotechnologies
- Decided: Aug 22, 2003 after 14 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
No predicates in its family tree.
252 later devices descend from it; 2 cite it directly.
0 of 253 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K072055: Lava Frame, Lava Frame Shade (2008), 176 descendants of its own
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST (2012), 165 descendants of its own
- K150203: Medentika CAD/CAM Abutments (2015), 129 descendants of its own
- K150367: Neodent Implant System (2015), 89 descendants of its own

## Indications for use
ALTATEC BIOTECHNOLOGIES implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila. The Ti-Ceramic abutment is used with the mentioned implant supported restorations where high aesthetics are desired.

Source page: https://510kreport.com/device/K032448
Methodology: https://510kreport.com/methodology