# K133613: Intra-Lock Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Intra-Lock International, Inc.
- Decided: Mar 20, 2014 after 115 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). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103194: Intra-Lock Dental Implants with Blossom, Intra-Lock International, Inc. (2011) Summary page 1.
- K073268: Biohorizons Internal Implant System, BioHorizons Implant Systems, Inc. (2008) Summary page 1.
- K073282: Biohorizons Single-Stage Implant System, BioHorizons Implant Systems, Inc. (2008) Summary page 1.
- K071638: Biohorizons Tapered Internal Implant System, BioHorizons Implant Systems, Inc. (2007) Summary page 1.

## Indications for use
Intra-LockID 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®D 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/K133613
Methodology: https://510kreport.com/methodology