# K120736: SR Phonares II

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: May 14, 2012 after 66 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K132984: SR Vivodent S, SR Orthotyp S, SR Ortholingual S (2014), 0 descendants of its own

## Indications for use
SIR Phonares 11 denture teeth are intended to be used for complete and partial denture prosthetics including hybrid dentures and implant-supported dentures.

Source page: https://510kreport.com/device/K120736
Methodology: https://510kreport.com/methodology