510(k) · Cleared
ClearedSmart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. · EBF Material, Tooth Shade, Resin
Cleared on Apr 23, 2026 as substantially equivalent to K222623 (Sprintray, Inc., 2022) after a 93-day review. Its family tree reaches back 9 generations to 2004.
- Decided
- Apr 23, 2026
- Review
- 93 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K042819 (2004). 31 ancestors in all, the oldest K901789 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 5 generations between
- 3 generations backK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- 2 generations backK210977 E-Dent 1000Envisiontec GmbH · 2021
- 1 generation backK222623 Digital CrownSprintray, Inc. · 2022
- This deviceK260152 Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT…Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. · 2026
Show all 9 generations
- Root · 9 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 8 generations backK091388 GCUC-505GC America, Inc. · 2009
- 7 generations backK123631 MFP-051GC America, Inc. · 2013
- 6 generations backK133824 CerasmartGC America, Inc. · 2014
- 5 generations backK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- 4 generations backK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- 3 generations backK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- 2 generations backK210977 E-Dent 1000Envisiontec GmbH · 2021
- 1 generation backK222623 Digital CrownSprintray, Inc. · 2022
- This deviceK260152 Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT…Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| −8 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| −7 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| −6 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| −5 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| −4 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| −3 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
| −2 | K210977 | E-Dent 1000 | Envisiontec GmbH | 2021 | — |
| −1 | K222623 | Digital Crown | Sprintray, Inc. | 2022 | — |
| 0 (this device) | K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K222623 | Digital CrownSummary page 5…Product Code(s) EBF, EBI, ELM | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K222623 Digital Crown EBF Device Description Summary 21 CFR 807.92(a)(4) Smart Print Bio Vitality is a light-cured, methacrylate-based r… | 2022 |
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 22 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 31 ancestors has a recall of any class.
- 2 other devices also cite its predicate K222623.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
Smart Print Bio Vitality is a light-curable resin intended for the fabrication of definitive dental restorations. The material can be used to produce single crowns, veneers, inlays, onlays, and artificial teeth for dental prostheses. It is also suitable for the production of removable definitive full dentures, as well as individual and removable monolithic full and partial dentures in dental offices and laboratories. The product is indicated for anterior and posterior restorations, providing an alternative to conventional restorative materials in both clinical and laboratory settings.
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/K260152 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260152: Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260152
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026