# K130140: Intra-Lock OP Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Intra-Lock International
- Decided: Aug 1, 2013 after 191 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K960026 (1996). 87 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052997: Zimmer Dental One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 1.
- K062281: Zimmer One-Piece Implant, 4.7MM, Straight, Models ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16, Zimmer Dental, Inc. (2006) Summary page 1.
- K050970: Milo Dental Implant System, Intra-Lock International (2005) Summary page 1.
- K103194: Intra-Lock Dental Implants with Blossom, Intra-Lock International, Inc. (2011) Summary page 1.

## Most influential descendants
- K132178: Mostdi Dental Implant System (2014), 0 descendants of its own

## Indications for use
The 3.0mm Intra-Lock® OP Dental implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral and central incisors. Multiple implants may be restored after a period of delayed loading or placed in immediate function when good primary stability is achieved with appropriate occlusal loading in order to restore normal teeth function. Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

Source page: https://510kreport.com/device/K130140
Methodology: https://510kreport.com/methodology