# K023649: Vitique System

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Jan 17, 2003 after 79 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933139 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971372: Variolink II, Ivoclar North America, Inc. (1997) Summary page 1.
- K972858: Kerr Nexus One Bottle Adhesive, Sybron Dental Specialties, Inc. (1997) Summary page 1.
- K022476: Relyx Rmgip, 3M Company (2002)
- K933139: 3M Vitremer Luting Cement, 3M Company (1994) Summary page 1.
- K980922: Protec Cem., Ivoclar North America, Inc. (1998) Summary page 1.
- (no number) Panavia F: named in the summary without a submission number
- (no number) Calibra: named in the summary without a submission number
- (no number) Principle: named in the summary without a submission number

## Indications for use
The Vitique System consists of a highly aesthetic luting cement in various shades, Try-In pastes that precisely match the corresponding cement shade to approximate the final result, a silanating agent to prepare ceramic surfaces for bonding, and a bonding system (etching gel, bonding system) for bonding to tooth structure. The Vitique System is intended for use in permanent luting of definitive restorations of all kinds (metal, ceramic, composite), including veneers, crowns and bridges, onlays, telescopic crowns, attachments, pins and posts, orthodontic appliances, luting of ornaments, splinting etc. as well as a add-on for resin based materials The Try-in pastes may also be used as a general water soluble separating agent (e.g. isolating material for use with prefabricated crowns, retraction cords etc.) or as an oxyguard gel.

Source page: https://510kreport.com/device/K023649
Methodology: https://510kreport.com/methodology