# K021322: Endossous Implants

- Pathway: 510(k) (Abbreviated)
- Applicant: Intra-Lock International
- Decided: Jul 24, 2002 after 90 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: 2 generations back to K894595 (1990). 13 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944683: Branemark System 3.3MM Fixture, Nobelpharma USA, Inc. (1995) Summary page 1.
- K945398: Branemark System (R) Mkii Self-Tapping Fixture, Nobelpharma USA, Inc. (1995) Summary page 1.
- K950624: HA- and TPS- Restore Self Tapping Dental Implant System, Lifecore Biomedical, Inc. (1995) Summary page 1.
- K003226: The Lifecore Stage-1 Single Stage RBM Dental Implant System, Lifecore Biomedical, Inc. (2001)
- K984104: Iti Dental Implant System, Straumann USA (1999). Our reading of the summary gave K994104, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ITI Straumann One Part Implants”.

## Most influential descendants
- K103194: Intra-Lock Dental Implants with Blossom (2011), 5 descendants of its own
- 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

## Indications for use
The Intra-Lock 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 prosthesis, from single tooth replacement to full arch reconstruction.

Source page: https://510kreport.com/device/K021322
Methodology: https://510kreport.com/methodology