# K092261: Defcon Tsa/TSH Dental Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Impladent, S.L.
- Decided: Jul 23, 2010 after 360 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: 9 generations back to K894595 (1990). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083550: Straumann Dental Implant System, Straumann USA (2009) Summary page 1.
- K033984: Straumann Dental Implant System, Institut Straumann AG (2004) Summary page 1.
- K083205: Nobelactive 8.5 MM & 18.0 MM, Nobel Biocare AB (2009) Summary page 1.
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 1.
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 1.

## Indications for use
DEFCON TSA/TSH implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. DEFCON TSA/TSH implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. Implants are intended for immediate loading on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirement detailed in the surgical manual is satisfied. When placing implants in the posterior region, we recommend using only large diameter (06.0 mm and above) implants. Specific indications for small diameter (03.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.

Source page: https://510kreport.com/device/K092261
Methodology: https://510kreport.com/methodology