# K023035: SR Vivotac/SR Orthotac, Modifier Monomer & Polymer

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Dec 2, 2002 after 81 days
- Product code: ELM (Denture, Plastic, Teeth)
- Device class: 2
- Regulation: 21 CFR 872.3590
- 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 no predicate by number.

## Indications for use
SR VivoTAC/SR OrthoTAC are radiopaque denture teeth intended to be used for determining the future placement, location and angulation of dental implants. The Modifier Polymer and Monomer can be utilized to lengthen the cervical region so that the entire length of the tooth can be made of radiopaque material.

Source page: https://510kreport.com/device/K023035
Methodology: https://510kreport.com/methodology