# K252197: Nobel Biocare S Series Implants

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Feb 18, 2026 after 219 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). 96 ancestors in all.
No later device cites it as a predicate yet.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202344: TiUltra Implants and Xeal Abutments, Nobel Biocare AB (2020) Summary page 6.

## Indications for use
NobelActive® S TiUltra™ and NobelActive® S TiUnite® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. NobelActive® S TiUltra™ and NobelActive® S TiUnite® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants are indicated for single or multiple unit restorations. The NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants can be used in splinted or non-splinted applications. The NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel™ S TiUltra™ and NobelParallel™ S TiUnite® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel™ S TiUltra™ and NobelParallel™ S TiUnite® implants are indicated for single or multiple restorations in splinted or non-splinted applications. This can be achieved by 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with <7 mm length are for delayed loading only when appropriate stability has been achieved.

Source page: https://510kreport.com/device/K252197
Methodology: https://510kreport.com/methodology