# K983563: Imcor 4.00 & 5.00MM Self-Tapping Locktite Implants, Imcor 4.00 & 5.00MM Self-Tapping HA Coasted Locktite Implants, and I

- Pathway: 510(k) (Traditional)
- Applicant: Imcor
- Decided: Jan 11, 1999 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
IMCOR implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients. The IMCOR Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The use of the IMCOR implant is the same as currently accepted uses for dental implants already in the marketplace. All components are to be used as labeled. Components are not intended to be bent by the clinician.

Source page: https://510kreport.com/device/K983563
Methodology: https://510kreport.com/methodology