# K202942: Straumann 4 mm Short Implants

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC
- Decided: Feb 8, 2021 after 131 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 K894595 (1990). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130222: Straumann Dental Implant System, Straumann USA, LLC (2013) Summary page 4.

## Indications for use
Straumann® 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and 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. The 4 mm Short Implants are specifically recommended for: • Fixed partial dentures/splinted units (one implant per unit) • Pontic cases in combination with at least one longer implant • Fully edentulous cases with at least one 4 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants

Source page: https://510kreport.com/device/K202942
Methodology: https://510kreport.com/methodology