# K201681: Straumann Immediate Temporary Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Mar 18, 2021 after 269 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K960026 (1996). 161 ancestors in all.
No later device cites it as a predicate yet.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122192: NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary Abutment, Cad-Temp, Pmma WN Tem, Straumann USA, LLC (2012) Summary page 4.
- K192401: Straumann Screw-Retained Abutments, Straumann USA, LLC (2020) Summary page 4.
- K181703: Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments, Institut Straumann AG (2018) Summary page 4.
- K190662: MRI Compatibility for Existing Straumann Dental Implant Systems, Straumann USA, LLC (2019) Summary page 4.
- K041070: Straumann Temporary Coping, The Straumann Co. (2004) Summary page 4.

## Indications for use
The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to be placed into Straumann dental implants (BL, BLT or BLX) to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase for up to 180 days. The Straumann Immediate Temporary Abutment and associated Plastic Coping must be placed out of occlusion.

Source page: https://510kreport.com/device/K201681
Methodology: https://510kreport.com/methodology