# K243478: Straumann InLab Validated Workflow

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Feb 19, 2025 after 103 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: 16 generations back to K894844 (1990). 190 ancestors in all.
No later device cites it as a predicate yet.
0 of 191 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171649: Straumann CARES M-Series CAD/CAM System, Institut Straumann AG (2018) Summary page 6.

## Indications for use
Patient-specific abutment restorations, milled from Pre-milled Abutment Blanks (PMABs), are indicated for single tooth replacement and multiple tooth restorations. They are directly connected to various endosseous dental implant systems using a basal screw. Patient-specific abutment restorations milled from Pre-milled Abutment Blanks are to be digitally designed and milled using the Straumann InLab Validated Workflow. The Straumann InLab Validated Workflow is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, pre-milled abutment blanks, milling machines and associated tooling and accessories.

Source page: https://510kreport.com/device/K243478
Methodology: https://510kreport.com/methodology