# K252727: Neodent InLab Validated Workflow

- Pathway: 510(k) (Traditional)
- Applicant: JJGC Indústria e Comércio de Materiais Dentários S.A.
- Decided: Jan 7, 2026 after 132 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: 13 generations back to K894595 (1990). 90 ancestors in all.
No later device cites it as a predicate yet.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242686: Neodent Implant System, Jjgc Indústria E Comércia DE Materiais Dentários S.A. (2024) Summary page 6.

## Indications for use
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The digitally designed personalized copings to be used with the Direct Connection Screw to Multi-Unit Abutment are to be: * Sent to Straumann for manufacture at a validated milling center, or * Manufactured following the Neodent InLab Validated Workflow. The Neodent InLab Validated Workflow is indicated for the design and fabrication of screw-retained multi-unit restorations for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components: scan files from intra-oral scanners, CAD software, CAM software, milling machines and associated tooling and accessories.

Source page: https://510kreport.com/device/K252727
Methodology: https://510kreport.com/methodology