# K973049: Imcor Externally Hexed, Self-Tapping Screw Implant Surgical Drilling System

- Pathway: 510(k) (Traditional)
- Applicant: Imcor
- Decided: Nov 13, 1997 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
IMCORT™ implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients. The cover screw is used to protect the top of the implant and the internal threads during the healing process. The surgical drills are intended to be used to create the osteotomy for placement of the dental implant. 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 and restorative system 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, cast or altered by the clinician.

Source page: https://510kreport.com/device/K973049
Methodology: https://510kreport.com/methodology