510(k) · Cleared
ClearedSaremco Print CROWNTEC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saremco Dental AG · EBF Material, Tooth Shade, Resin
Cleared on Jan 21, 2022 as substantially equivalent to K202846 (Graphy, Inc., 2021) and 1 other predicate after a 106-day review. Its family tree reaches back 8 generations to 2004. 6 later devices descend from it.
- Decided
- Jan 21, 2022
- Review
- 106 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K042819 (2004). 16 ancestors in all, the oldest K920425 (1992). 6 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 7 generations backK091388 GCUC-505GC America, Inc. · 2009
- 6 generations backK123631 MFP-051GC America, Inc. · 2013
- 5 generations backK133824 CerasmartGC America, Inc. · 2014
- 4 generations backK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- 3 generations backK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- 2 generations backK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- 1 generation backK202846 Tera HarzGraphy, Inc. · 2021
- This deviceK213343 Saremco Print CROWNTECSaremco Dental AG · 2022
- Descendant · cites it directly · 3 of its ownK233596 VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2023
- Descendant · 2 generations on · 1 of its ownK253053 Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)Hangzhou SHINING3D Dental Technology Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK261356 Dura-CrownHangzhou SHINING3D Dental Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK250497 Additive Manufacturing (Light Curing) Crown Bridge ResinAidite (Qinhuangdao) Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK241071 NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K233596VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2023 · cites it directly3descendants
- K253053Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)Hangzhou SHINING3D Dental Technology Co., Ltd. · 2025 · 2 generations on1descendant
- K261356Dura-CrownHangzhou SHINING3D Dental Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K250497Additive Manufacturing (Light Curing) Crown Bridge ResinAidite (Qinhuangdao) Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K241071NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| −7 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| −6 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| −5 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| −4 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| −3 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| −2 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
| −1 | K202846 | Tera Harz | Graphy, Inc. | 2021 | — |
| 0 (this device) | K213343 | Saremco Print CROWNTEC | Saremco Dental AG | 2022 | — |
| +1 | K233596 | VarseoSmile TriniQ | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2023 | — |
| +2 | K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025 | — |
| +3 | K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026 | — |
| +2 | K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025 | — |
| +1 | K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K202846 | Tera HarzSummary page 4…ic Denture Tooth – 21 CFR 872.3590 Product Codes EBF & EBG Subsequent Product Code PZY Predicate Devices TERA HARZ (Graphy Inc.) – K202846 – Primary Predicate Crowntec – 510(k) Premarket Notification Page 1 of 7 === Page 5 ==… | 2021 |
| * | K172398 | DENTCA DENTURE TeethSummary page 5…Page 1 of 7 VarseoSmile Crownplus (BEGO Bremer Goldschlägerei) – K201668 – Reference Predicate Dentca Denture Teeth (Dentca, Inc.) K172398 – Secondary Predicate Device Description saremco print CROWNTEC is a resin-based material for the production of permanent and t… | 2017 |
| † | K201668 | VarseoSmile Crown plus | 2020 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K233596 (Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG, 2023) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K202846.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
saremco print CROWNTEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print CROWNTEC material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations. saremco print CROWNTEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213343: Saremco Print CROWNTEC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213343
Report an extraction error
Are you the manufacturer?
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