# K031322: Intra-Lock Hydroxyapatite Coated Implants

- Pathway: 510(k) (Abbreviated)
- Applicant: Intra-Lock International
- Decided: Dec 23, 2003 after 242 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: 1 generation back to K960288 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021244: Ace HA Screw Dental Implant System, Ace Surgical Supply Co., Inc. (2002) Summary page 1.
- K003045: HA-TI (Hand Titanium Screw) Implant, Hati Dental Ag. (2001) Summary page 1.
- K010343: BMR Dental Implant System, Model 3.3XX, Either HA or TPS Coated, 3.308, 3.310,3.312, 3.314 3.316, Buck Medical Research (2001) Summary page 1.
- K962845: Replace HA Coated Implants, Steri-Oss, Inc. (1996) Summary page 1.
- K981516: Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant HA Coated , Refer to Table 1 in Sub, Sterngold/Implamed (1998) Summary page 1.
- K960288: HA & TPS Restore Self Tapping Dental Implant System, Lifecore Biomedical, Inc. (1996) Summary page 1.

## Indications for use
The Intra-Lock Hydroxyapatite Coated Implants have 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/K031322
Methodology: https://510kreport.com/methodology