# K234049: Straumann® BLC and TLC Implants - Line extension

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Mar 20, 2024 after 90 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: 15 generations back to K894595 (1990). 91 ancestors in all.
No later device cites it as a predicate yet.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230108: Straumann® BLC and TLC Implants, Institut Straumann AG (2023) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K234049
Methodology: https://510kreport.com/methodology