# K012473: Vident Hextop, Synocta in-Ceram Blank/Coping Manufactured by Vident

- Pathway: 510(k) (Traditional)
- Applicant: Vident
- Decided: Sep 11, 2002 after 405 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.
266 later devices descend from it; 1 cites it directly.
0 of 267 devices 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.

## Most influential descendants
- K061277: Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping (2007), 265 descendants of its own
- K072151: P.004 RC Cares Titanium and Ceramic Abutments (2007), 264 descendants of its own
- K081005: P.004 NC Cares Titanium and Ceramic Abutments (2008), 263 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K082545: Straumann NN Cares Titanium and Ceramic Abutments (2008), 171 descendants of its own

## Indications for use
Ceramic hextop abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis. The IT10 ceramic coping is intended to be seated on the implantlabutment complex and serve as a base for the prosthetic reconstruction. The prefabricated coping provides a machined inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration.

Source page: https://510kreport.com/device/K012473
Methodology: https://510kreport.com/methodology