# K132984: SR Vivodent S, SR Orthotyp S, SR Ortholingual S

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Jan 14, 2014 after 112 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
Longest line of descent: 1 generation back to K844349 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844349: SR Vivodent PE Anterior Teeth & SR Orthotyp RE Pos, Ivoclar USA, Inc. (1984) Summary page 1.
- K120736: SR Phonares II, Ivoclar Vivadent, AG (2012) Summary page 1.

## Indications for use
Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.

Source page: https://510kreport.com/device/K132984
Methodology: https://510kreport.com/methodology