# K063768: Titanium Scalloped Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Vident
- Decided: Jun 27, 2007 after 189 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Titanium Scalloped abutments are designed for use with Nobel Biocare® BrinemarkTM external hex, 3I external hex and Zimmer® internal hex dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis cemented onto the abutment. The abutments are indicated for full arch or partially endentulous patient restoration including single implant restorations,

Source page: https://510kreport.com/device/K063768
Methodology: https://510kreport.com/methodology