# K081226: Simpact Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Simpact, LLC
- Decided: Sep 12, 2008 after 135 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: 10 generations back to K960026 (1996). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051614: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics, Lifecore Biomedical, Inc. (2005) Summary page 1.
- K041509: Ankylos Dental Implant System, Friadent GmbH (2004) Summary page 1.
- K012681: Ankylos, Dentsply Ceramco (2003)

## Cited in the summary but kept off the family tree
- K000099: Camlog Screw Implant System, Altatec Biotechnologies (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K083141: Simpact Endosseous Dental Implant System (2008), 0 descendants of its own

## Indications for use
Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae; in support of single or multiple-unit restorations including: cement retained terminal or intermediate abutment support for fixed bridgework. The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket. The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.

Source page: https://510kreport.com/device/K081226
Methodology: https://510kreport.com/methodology