# K090397: Xpi Angled Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Keystone Dental, Inc.
- Decided: Jun 5, 2009 after 108 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. The FDA summary names no predicate by number.

## Indications for use
The XP1 Angled Abutment is intended for use in conjunction with the XP1 Dental Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. The angled abutment is indicated in cases where angle correction is required.

Source page: https://510kreport.com/device/K090397
Methodology: https://510kreport.com/methodology