510(k) · Cleared
ClearedVITA VMLC Primer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vita Zahnfabrik H. Rauter GmbH & Co. Kg. · KLE Agent, Tooth Bonding, Resin
Cleared on Feb 23, 2026 as substantially equivalent to K974089 (Kuraray America, Inc., 1997) and 1 other predicate after a 276-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Feb 23, 2026
- Review
- 276 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K902115 (1990). 24 ancestors in all, the oldest K833757 (1984). No later device cites it as a predicate yet.
- Root · 6 generations backK902115 Palapress (R) Vario ResinKulzer, Inc. · 1990
- 5 generations backK972573 Liqcrylic Pro Dental ResinDentsply Intl. · 1997
- 4 generations backK991220 Vitron HEspe Dental AG · 1999
- 3 generations backK992645 SinfonyEspe Dental AG · 1999
- 2 generations backK152373 VITA VM LC FlowVita Zahnfabrik H.Rauter GmbH & Co. · 2015
- 1 generation backK240660 Signum composite flow; Signum universal bond; Signum metal bond…Kulzer, LLC · 2024
- This deviceK251587 VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902115 | Palapress (R) Vario Resin | Kulzer, Inc. | 1990 | — |
| −5 | K972573 | Liqcrylic Pro Dental Resin | Dentsply Intl. | 1997 | — |
| −4 | K991220 | Vitron H | Espe Dental AG | 1999 | — |
| −3 | K992645 | Sinfony | Espe Dental AG | 1999 | — |
| −2 | K152373 | VITA VM LC Flow | Vita Zahnfabrik H.Rauter GmbH & Co. | 2015 | — |
| −1 | K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum… | Kulzer, LLC | 2024 | — |
| 0 (this device) | K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2013 | 2 | 0 |
| 2021 | 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 KLE? 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 KLE device
- #1 K262252 MPa Max adhesivescore 15.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K974089 | Alloy PrimerSummary page 5…assification Name: Agent, Tooth Bonding, Resin Regulation Number: 21 CFR 872.3200 Product Code: KLE Class: II Predicate Devices Primary predicate: Kuraray Alloy Primer (K974089) Secondary predicate: Signum Universal Bond (K240660) Device Description VITA VM LC Primer is a two-component dental bonding sys… | 1997 |
| * | K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite…Summary page 5…tion Number: 21 CFR 872.3200 Product Code: KLE Class: II Predicate Devices Primary predicate: Kuraray Alloy Primer (K974089) Secondary predicate: Signum Universal Bond (K240660) Device Description VITA VM LC Primer is a two-component dental bonding system (Primer I and Primer II) used to promote adhesion… | 2024 |
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 36 years and passes through 6 companies; a new generation was cleared every 7.1 years on median.
- None of the 24 ancestors has a recall.
- 2 other devices also cite its predicate K974089.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · KLE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 2025
MAUDE reports naming product code KLE, 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 | 14 | 71 | 2 | 18 |
| 2008 | 3 | 66 | 0 | 9 |
| 2009 | 7 | 79 | 1 | 11 |
| 2010 | 8 | 93 | 1 | 13 |
| 2011 | 10 | 100 | 0 | 69 |
| 2012 | 5 | 66 | 0 | 176 |
| 2013 | 11 | 115 | 0 | 248 |
| 2014 | 6 | 120 | 0 | 260 |
| 2015 | 10 | 118 | 0 | 100 |
| 2016 | 3 | 148 | 1 | 47 |
| 2017 | 4 | 171 | 1 | 42 |
| 2018 | 8 | 124 | 0 | 31 |
| 2019 | 6 | 143 | 0 | 20 |
| 2020 | 6 | 195 | 0 | 6 |
| 2021 | 4 | 163 | 0 | 6 |
| 2022 | 8 | 98 | 0 | 7 |
| 2023 | 6 | 75 | 0 | 7 |
| 2024 | 7 | 61 | 1 | 12 |
| 2025 | 3 | 149 | 0 | 3 |
| 2026 | 7 | 84 | 0 | — |
What is it indicated for?
* Adhesive bonding of metal substructure surfaces (non-precious metal alloys, PM alloys, titanium) with (meth-)acrylate-based resins/composites
* Adhesive bonding of ZrO2 substructure surfaces with (meth-)acrylate-based resins/composites
* Adhesive bonding of cross-linked composites/resins such as VITA CAD Temp or of high-performance polymers (PEEK, PEKK) with (meth-)acrylate-based resins/composites
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251587 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251587: VITA VMLC Primer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251587
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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