# K960371: Interpore Threaded Implant

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Intl.
- Decided: Mar 8, 1996 after 42 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Nobelpharma Threaded Implants: named in the summary without a submission number
- (no number) Implant Innovations, Inc. (3i) Threaded Implants: named in the summary without a submission number
- (no number) Lifecore Threaded Implants: named in the summary without a submission number

## Indications for use
The INTERPORE Self-Tapping Threaded Implant is indicated for oral reconstruction in the totally edentulous mandible or maxilla, in large edentulous spans, for bilateral and unilateral free-ends and in restoration of single tooth edentulous spaces. It is designed to become an osteointegrated prosthesis allowing the attachment of removable and fixed partial or complete prosthodontic appliances. The external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications.

Source page: https://510kreport.com/device/K960371
Methodology: https://510kreport.com/methodology