# K053088: Slactive Implants

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Feb 27, 2006 after 117 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: 7 generations back to K894595 (1990). 35 ancestors in all.
295 later devices descend from it; 10 cite it directly.
0 of 331 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971578: Endosseous Dental Implant, Straumann USA (1997) Summary page 1.
- K033984: Straumann Dental Implant System, Institut Straumann AG (2004) Summary page 1.

## Most influential descendants
- K083550: Straumann Dental Implant System (2009), 228 descendants of its own
- K060958: Straumann Narrow Neck Implants (2006), 228 descendants of its own
- K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System (2011), 222 descendants of its own
- K113283: NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC Basal Screw  Cementable Abutments (2011), 166 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

## Indications for use
SLActive implants are for single-stage or two-stage surgical procedures. SLActive implants are intended for immediate placement and hinction on singu! tooth and/c multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases.

Source page: https://510kreport.com/device/K053088
Methodology: https://510kreport.com/methodology