# K220612: PrimeLOC Attachment System

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Product Brands, Inc.
- Decided: Jun 6, 2022 after 95 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: 1 generation back to K083324 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083324: Locator Implant Anchor Attachment System, Zest Anchors, Inc. (2009) Summary page 4.

## Indications for use
The PrimeLOC Attachment System is designed to facilitate patient removal of a dental prosthesis for use with full arch overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. PrimeLOC Attachment Implant Compatibility Implant Configurations Zimmer Biomet Dental Tapered Screw Vent Implant 3.5mm Platform (3.7mm and 4.1mm body diameters)

Source page: https://510kreport.com/device/K220612
Methodology: https://510kreport.com/methodology