# K013869: SR Ivocron

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Aug 28, 2002 after 280 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- 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
- K052781: Breformance (2005), 0 descendants of its own

## Indications for use
Cold technique: With the Cold Liquid, SR lvocron may be used for temporaries, securing ground denture teeth, and repair of PMMA. Hot technique: When used with the Hot Liquid, this technique may be used for temporaries and inexpensive crowns and bridges. For crowns and bridges, SR lvocron must be layered over a metal framework. Press (flasking) technique: For the press technique, SR lvocron is mixed with the Press Liquid and may be used for temporaries and inexpensive crowns and bridges. For crowns and bridges, the material must be pressed over a metal framework.

Source page: https://510kreport.com/device/K013869
Methodology: https://510kreport.com/methodology