510(k) · Cleared
ClearedVericore Gradient Temporary Disc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Whip Mix Corporation · EBG Crown And Bridge, Temporary, Resin
Cleared on May 11, 2016 as substantially equivalent to K131664 (White Peaks Dental Systems GmbH & Co. KG, 2013) and 2 other predicates after a 258-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- May 11, 2016
- Review
- 258 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K024250 (2003). 14 ancestors in all, the oldest K002041 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK024250 Match Press Pressable CeramicDavis Schottlander & Davis, Ltd. · 2003
- 3 generations backK043221 Willi Geller Creation CP PorcelainJensen Industries, Inc. · 2004
- 2 generations backK070114 Creation CP-ZI PorcelainJensen Industries, Inc. · 2007
- 1 generation backK111743 The Insync Ceramic SystemJensen Industries, Inc. · 2011
- This deviceK152443 Vericore Gradient Temporary DiscWhip Mix Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K024250 | Match Press Pressable Ceramic | Davis Schottlander & Davis, Ltd. | 2003 | — |
| −3 | K043221 | Willi Geller Creation CP Porcelain | Jensen Industries, Inc. | 2004 | — |
| −2 | K070114 | Creation CP-ZI Porcelain | Jensen Industries, Inc. | 2007 | — |
| −1 | K111743 | The Insync Ceramic System | Jensen Industries, Inc. | 2011 | — |
| 0 (this device) | K152443 | Vericore Gradient Temporary Disc | Whip Mix Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 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 EBG? 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 EBG device
- #1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K131664 | Copra Temp Pmma-DiskSummary page 5…N Whip Mix claims three predicates for our Vericore ® Gradient Temporary Discs. The primary predicate is to Copra-Temp discs manufactured by White Peaks Dental Systems (K131664). The Indications for Use are similar and both devices use Evonik as the supplier of the PMMA raw material supplier. Both devices… | 2013 |
| * | K142670 | Vericore Zirconia BlanksSummary page 5…en used in accordance with the Instructions For Use. The secondary and reference predicates are to demonstrate substantial equivalence with the shade materials. Whip Mix K142670 and Jensen Dental K111743 are referenced. Whip Mix claims these predicates for the shading ingredient of red, yellow, and blue. T… | 2014 |
| * | K111743 | The Insync Ceramic SystemSummary page 5…the Instructions For Use. The secondary and reference predicates are to demonstrate substantial equivalence with the shade materials. Whip Mix K142670 and Jensen Dental K111743 are referenced. Whip Mix claims these predicates for the shading ingredient of red, yellow, and blue. The rest of the information… | 2011 |
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 13 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 14 ancestors has a recall.
- 1 other device also cites its predicate K131664.
How does its category compare?
All EBG devicesEBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · EBG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBG
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBG
1in 2025
MAUDE reports naming product code EBG, 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 | 3 | 64 | 0 | 4 |
| 2008 | 9 | 83 | 0 | 4 |
| 2009 | 2 | — | 1 | 1 |
| 2010 | 5 | 103 | 0 | 1 |
| 2011 | 10 | 96 | 0 | 1 |
| 2012 | 5 | 90 | 0 | 5 |
| 2013 | 2 | — | 0 | 11 |
| 2014 | 3 | 114 | 0 | 23 |
| 2015 | 6 | 209 | 0 | 26 |
| 2016 | 4 | 163 | 0 | 8 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 4 | 202 | 0 | 0 |
| 2019 | 6 | 98 | 0 | 6 |
| 2020 | 14 | 194 | 1 | 2 |
| 2021 | 3 | 265 | 0 | 4 |
| 2022 | 3 | 73 | 0 | 2 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 5 | 144 | 0 | 0 |
| 2025 | 4 | 106 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Vericore ® Gradient Temporary discs is a device made from Polymethylmethacrlate. It is used to mill/fabricate temporary crown or bridge for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed virtually by a dental professional/technician then manufactured (milled) using CAD technology.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152443: Vericore Gradient Temporary Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152443
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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