# K103194: Intra-Lock Dental Implants with Blossom

- Pathway: 510(k) (Abbreviated)
- Applicant: Intra-Lock International, Inc.
- Decided: Apr 21, 2011 after 174 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: 9 generations back to K925765 (1993). 67 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021322: Endossous Implants, Intra-Lock International (2002) Summary page 1.
- K072363: Nanotite Prevail,Certain,Parellel Walled,Tapered,External Hex, Biomet 3i, Inc. (2008) Summary page 1.

## Most influential descendants
- K130140: Intra-Lock OP Dental Implant (2013), 1 descendant of its own
- K151970: KJ Mini Implant System (2016), 0 descendants of its own
- K132178: Mostdi Dental Implant System (2014), 0 descendants of its own
- K133613: Intra-Lock Dental Implants (2014), 0 descendants of its own
- K111199: Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled Abutments (2011), 0 descendants of its own

## Indications for use
The Intra-Lock Dental Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prothesis, from single tooth replacement to full arch reconstruction. They are intended for immediate function on single 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/K103194
Methodology: https://510kreport.com/methodology