510(k) · Cleared
ClearedNobilplast Denture Resin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cmp Industries, LLC · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Oct 2, 2017 as substantially equivalent to K072402 (Cmp Industries, LLC, 2007) and 2 other predicates after a 237-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Oct 2, 2017
- Review
- 237 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K902115 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK902115 Palapress (R) Vario ResinKulzer, Inc. · 1990
- 2 generations backK110037 Palaxpress Ultra Powder (Pink); Palaxpress Ultra LiquidHeraeus Kulzer, LLC · 2011
- 1 generation backK130680 Acrytone, Rezen NF, and Iso Fast Denture ResinsDentsoll, Inc. · 2013
- This deviceK170375 Nobilplast Denture ResinCmp Industries, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902115 | Palapress (R) Vario Resin | Kulzer, Inc. | 1990 | — |
| −2 | K110037 | Palaxpress Ultra Powder (Pink); Palaxpress Ultra Liquid | Heraeus Kulzer, LLC | 2011 | — |
| −1 | K130680 | Acrytone, Rezen NF, and Iso Fast Denture Resins | Dentsoll, Inc. | 2013 | — |
| 0 (this device) | K170375 | Nobilplast Denture Resin | Cmp Industries, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 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 EBI? 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 EBI device
- #1 K250617 Apex Flexscore 18.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K072402 | Flex-Star VSummary page 4…for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. Design: Nobilplast Denture Resin is designed exactly following K072402 FlexStar V. Both products share the same material type (polyamide), pigments, shading operation, packaging configuration, packagi… | 2007 |
| * | K130680 | Acrytone, Rezen NF, and Iso Fast Denture ResinsSummary page 5…Analysis per ASTM E1311, Melt Flow Rate Analysis, Izod Impact Strength per ISO 180 or ASTM D256. Primary Predicate Device: K072402 FlexStar V Resin Reference Devices: K130680 High Denture Resin, (pre-amendment) Valplast, K053060 TCS Unbreakable Biocompatibility: Nobilplast Denture Resin was used to mak… | 2013 |
| * | K053060 | TCS UnbreakableSummary page 5…d Impact Strength per ISO 180 or ASTM D256. Primary Predicate Device: K072402 FlexStar V Resin Reference Devices: K130680 High Denture Resin, (pre-amendment) Valplast, K053060 TCS Unbreakable Biocompatibility: Nobilplast Denture Resin was used to make partial dentures in final finished form as test arti… | 2006 |
| * | — | Valplast 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 27 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K072402.
How does its category compare?
All EBI devicesEBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · EBI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBI
79in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBI
34in 2025
MAUDE reports naming product code EBI, 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 | 10 | 53 | 0 | 7 |
| 2008 | 6 | 124 | 0 | 2 |
| 2009 | 3 | 234 | 0 | 5 |
| 2010 | 4 | 95 | 0 | 4 |
| 2011 | 11 | 113 | 0 | 6 |
| 2012 | 3 | 85 | 0 | 9 |
| 2013 | 5 | 135 | 0 | 5 |
| 2014 | 5 | 102 | 0 | 9 |
| 2015 | 9 | 106 | 0 | 8 |
| 2016 | 7 | 147 | 0 | 9 |
| 2017 | 8 | 196 | 0 | 2 |
| 2018 | 5 | 158 | 2 | 2 |
| 2019 | 4 | 127 | 0 | 10 |
| 2020 | 6 | 283 | 0 | 8 |
| 2021 | 4 | 99 | 0 | 25 |
| 2022 | 11 | 154 | 2 | 2 |
| 2023 | 11 | 96 | 0 | 13 |
| 2024 | 9 | 90 | 0 | 1 |
| 2025 | 11 | 79 | 0 | 34 |
| 2026 | 7 | 87 | 0 | — |
What is it indicated for?
Nobilplast Denture Resin is intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170375: Nobilplast Denture Resin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170375
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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