# K040951: SR Adoro

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: May 19, 2004 after 37 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For Metal Supported restorations with conventional cementation Guard - Veneering of metal supported restorations using SR Adoro Thermo Adoro Thermo Guard (e.g. telescope veneers) using SR - Veneering of combined dentures Adoro Thermo Guard - Veneering of partially removable implant superstructures using SR using SR Adoro Thermo - Veneering of gingival parts in partially removable implant superstructures Guard - Fabrication of long-term temporaries using SR Adoro Thermo Guard - Masking of model cast frameworks with SR Adoro Opaquer Pink. For Metal-Free restorations With Adhesive Cementation: - Inlays/Onlays/Veneers - Anterior crowns without Vectris framework - Anterior and posterior crowns with Vectrist framework - 3-unit anterior and posterior bridges using Vectris framework - 3-unit inlay-retained bridges with Vectris framework With Conventional Cementation - long-term temporaries with Vectris framework for a maximum duration of wear of 12 months. For removable prosthetics - Surface characterization of Ivoclar Vivadent denture teeth with SR Adoro Stains. Surfaces must subsequently be covered with SR Adoro layering material. - Shade and shape modifications of Ivoclar Vivadent denture teeth with SR Adoro layering material in conjuction with SR Composiv.

Source page: https://510kreport.com/device/K040951
Methodology: https://510kreport.com/methodology