510(k) · Cleared
ClearedVitique System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmg USA, Inc. · EMA Cement, Dental
Cleared on Jan 17, 2003 as substantially equivalent to K971372 (Ivoclar North America, Inc., 1997) and 4 other predicates after a 79-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jan 17, 2003
- Review
- 79 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K933139 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933139 | 3M Vitremer Luting Cement | 3M Company | 1994 | — |
| −1 | K022476 | Relyx Rmgip | 3M Company | 2002 | — |
| 0 (this device) | K023649 | Vitique System | Dmg USA, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EMA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971372 | Variolink IISummary page 1…cation is Class 11. 'redica te Devices: Product Name 510(k) # Manufacturer Variolink I1 K971372 Vivadent Nexus K9728 58 Kerr Panavia F… | 1997 |
| * | K972858 | Kerr Nexus One Bottle AdhesiveSummary page 1…510(k) # Manufacturer Variolink I1 K971372 Vivadent Nexus K9728 58 Kerr Panavia F unknown Kuraray Calibra… | 1997 |
| * | K022476 | Relyx Rmgip | 2002 |
| * | K933139 | 3M Vitremer Luting CementSummary page 1…unknown Dentsply Rely X KO22476 3M Vitremer K933 139 3M Principle unknown Dentsply ProTec Cem… | 1994 |
| * | K980922 | Protec Cem.Summary page 1…r K933 139 3M Principle unknown Dentsply ProTec Cem K980922 Vivadent Produc t Description: The Vi1 ique System consists of: Vitique Cement - a highly aesthetic luting c… | 1998 |
| * | — | Panavia F Named without a submission number | |
| * | — | Calibra Named without a submission number | |
| * | — | Principle Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- None of the 6 ancestors has a recall.
- 3 other devices also cite its predicate K971372.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
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)…
Read the full statement (126 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023649: Vitique System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023649
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026