# K150938: Straumann® Dental Implant System ¿ Roxolid® SLA Implants

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC
- Decided: Jul 24, 2015 after 108 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K894595 (1990). 89 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983742: Iti Dental Implant System, Institut Straumann AG (1999) Summary page 4.
- K012757: Iti Dental Implant System, Straumann USA (2001) Summary page 4.
- K033922: Modification to Iti Dental Implant System, Institut Straumann AG (2004) Summary page 4.
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 4.
- K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System, Straumann USA (2011) Summary page 4.
- K140878: Straumann Bone Level Tapered Implant, Straumann USA, LLC (2014) Summary page 4.

## Most influential descendants
- K230108: Straumann® BLC and TLC Implants (2023), 4 descendants of its own
- K240187: Tapered Pro Conical Implant System (2024), 2 descendants of its own
- K260061: BioHorizons CEREC Compatible Ti-Bases (2026), 0 descendants of its own
- K243521: Conical Ti Base abutments (2025), 0 descendants of its own
- K234049: Straumann® BLC and TLC Implants - Line extension (2024), 0 descendants of its own

## Recalls of this device
- Jul 14, 2016 · Class II · Z-2535-2016: Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
- Jul 14, 2016 · Class II · Z-2534-2016: Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration

## Indications for use
Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).

Source page: https://510kreport.com/device/K150938
Methodology: https://510kreport.com/methodology