# K223083: Straumann SLActive labeling changes

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Jun 22, 2023 after 265 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: 13 generations back to K894595 (1990). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171784: Straumann Dental Implant System, Straumann USA, LLC (2018) Summary page 6.

## Indications for use
Straumann® BLX Dental Implants, SLActive® Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. Straumann® TLX Dental Implants, SLActive® Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. Other Straumann® Tissue Level and Bone Level Dental Implants, SLActive® Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. Unless stated in specific indications, they can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. Specific indications for use: Straumann® Roxolid® Bone Level Tapered Implant ∅ 2.9 mm The Straumann® Roxolid® Bone Level Tapered implants ∅ 2.9 mm are indicated for single-unit reconstruction of incisors in the lower jaw and lateral incisors in the upper jaw. Straumann® Roxolid® Standard Plus 4 mm Short Implants Straumann® Roxolid® Standard Plus 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks. Straumann® Roxolid® Standard Plus 4 mm Short Implants are specifically indicated for: • Fixed denture prosthesis/splinted units (one implant per unit). • Pontic cases in combination with at least one longer implant. • Fully edentulous cases with at least one Straumann® Roxolid® Standard Plus 4 mm Short Implants in combination with 2 longer implants in the anterior region and at least four total implants. Titanium ∅ 3.3 mm implants ∅3.3 mm S and SP RN implants are to be used only for the following indications: Partially dentate jaws with implant-borne, fixed constructions: combine with a ∅4.1 mm implants and splint the superstructure.

Source page: https://510kreport.com/device/K223083
Methodology: https://510kreport.com/methodology