# K152845: Allied Biocompat Abutment for Nobel Replace Interface

- Pathway: 510(k) (Traditional)
- Applicant: Allied Dental Solutions
- Decided: Mar 14, 2016 after 167 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: 5 generations back to K894595 (1990). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053654: Atlantis Abutment for Nobel Replace Interface, Atlantis Components, Inc. (2006) Summary page 5.

## Indications for use
The Allied Biocompat abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the Allied Dental Solutions abutment to the endosseous implant. Allied Biocompat Abutments are compatible with the following Implant Manufacturer: Nobel Biocare Implant Line: Replace Select Straight and Select Straight One Stage, Replace Select Tapered and Select Tapered One Stage Implant Diameters: 3.5 (NP), 4.0 (RP), 5.0 (WP) and 6.0

Source page: https://510kreport.com/device/K152845
Methodology: https://510kreport.com/methodology