# K052951: Endopore Anatomic Endosseous Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Innova Life Sciences Corp.
- Decided: Jan 27, 2006 after 99 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: 3 generations back to K971196 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043190: Scalloped Endopore Endosseous Dental Implant System, Innova Life Sciences Corp. (2004) Summary page 1.
- K926354: Endo-Pore Endosseous Dental Implant System, Innova Corp. (1995) Summary page 1.
- K971196: Endopore Endosseous Dental Implant System, Innova Corp. (1997) Summary page 1.
- K032140: 5.0 X 5MM Endopore Endosseous Dental Implant System, Innova Life Sciences Corp. (2003) Summary page 1.

## Indications for use
ENDOPORE Anatomic dental implants may be used as artificial root components to support a prosthesis in an edentulous or partially edentulous mandible or maxilla. ENDOPORE Anatomic dental implants are provided in three diameters, each intended for surgical placement into specific regions of the mandible and maxilla. Diameters and their corresponding regions are: 3.75 mm provided in lengths of 10, 12, and 15 mm for the anterior mandible 5.0 mm provided in lengths of 8.5, 10, 12, and 15 mm for the anterior maxilla, and 4.5 nun provided in lengths of 8.5, 10, 12, and 15 mm for both the posterior mandible and posterior maxilla. The appropriate diameter of implant corresponding to the planned placement region should be selected. In addition, as with all dental implants, appropriate preoperative buccolingual width and crestal bone height measurements of the planned site should be made to ensure that adequate alveolar bone volume is available to accommodate the diameter and length of implant selected. If bone volume is not adequate, a press-fit ENDOPORE or threaded ENTEGRA implant of appropriate diameter and length may be considered for placement.

Source page: https://510kreport.com/device/K052951
Methodology: https://510kreport.com/methodology