# K252168: Straumann® BLC Implants - Indication Widening

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Mar 10, 2026 after 243 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: 12 generations back to K925765 (1993). 74 ancestors in all.
No later device cites it as a predicate yet.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212785: Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments, Blue Sky Bio, LLC (2022) Summary page 6.

## Indications for use
Straumann® dental implants for use in the pterygoid region are indicated in cases of severe jaw resorption for the functional and esthetic oral rehabilitation of the upper jaw in edentulous or partially edentulous patients. This indication is limited to Straumann® BLC bone-level implants with a length of 18 mm and a diameter of 3.75 mm (RB platform). Implants anchored in the pterygoid region shall be placed using a free-hand surgical technique and restored only in splinted applications utilizing at least two implants in combination with screw retained abutments.

Source page: https://510kreport.com/device/K252168
Methodology: https://510kreport.com/methodology