510(k) · Cleared
ClearedTera Harz
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graphy, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Jul 15, 2021 as substantially equivalent to K201668 (Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG, 2020) after a 293-day review. Its family tree reaches back 7 generations to 2004. 13 later devices descend from it.
- Decided
- Jul 15, 2021
- Review
- 293 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K042819 (2004). 14 ancestors in all, the oldest K920425 (1992). 13 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK042819 Tetric EvoceramIvoclar Vivadent, Inc. · 2004
- 6 generations backK091388 GCUC-505GC America, Inc. · 2009
- 5 generations backK123631 MFP-051GC America, Inc. · 2013
- 4 generations backK133824 CerasmartGC America, Inc. · 2014
- 3 generations backK160425 CAD/CAMouflage Milling BockPrismatik Dentalcraft, Inc. · 2016
- 2 generations backK162537 CAD/CAMouflage Milling BlockPrismatik Dentalcraft, Inc. · 2016
- 1 generation backK201668 VarseoSmile Crown plusBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2020
- This deviceK202846 Tera HarzGraphy, Inc. · 2021
- Descendant · cites it directly · 6 of its ownK213343 Saremco Print CROWNTECSaremco Dental AG · 2022
- Descendant · 2 generations on · 3 of its ownK233596 VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2023
- Descendant · cites it directly · 2 of its ownK222877 FREEPRINT crownDetax GmbH · 2022
- Descendant · 3 generations on · 1 of its ownK253053 Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)Hangzhou SHINING3D Dental Technology Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK233502 Tera Harz IIGraphy, Inc. · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K213343Saremco Print CROWNTECSaremco Dental AG · 2022 · cites it directly6descendants
- K233596VarseoSmile TriniQBego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · 2023 · 2 generations on3descendants
- K222877FREEPRINT crownDetax GmbH · 2022 · cites it directly2descendants
- K253053Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)Hangzhou SHINING3D Dental Technology Co., Ltd. · 2025 · 3 generations on1descendant
- K233502Tera Harz IIGraphy, Inc. · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K042819 | Tetric Evoceram | Ivoclar Vivadent, Inc. | 2004 | — |
| −6 | K091388 | GCUC-505 | GC America, Inc. | 2009 | — |
| −5 | K123631 | MFP-051 | GC America, Inc. | 2013 | — |
| −4 | K133824 | Cerasmart | GC America, Inc. | 2014 | — |
| −3 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016 | — |
| −2 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016 | — |
| −1 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2020 | — |
| 0 (this device) | K202846 | Tera Harz | Graphy, Inc. | 2021 | — |
| +1 | K213343 | Saremco Print CROWNTEC | Saremco Dental AG | 2022 | — |
| +2 | K233596 | VarseoSmile TriniQ | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 2023 | — |
| +1 | K222877 | FREEPRINT crown | Detax GmbH | 2022 | — |
| +3 | K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025 | — |
| +1 | K233502 | Tera Harz II | Graphy, Inc. | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 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 K253053 Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)score 15.8 · 10 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 |
|---|---|---|---|
| * | K201668 | VarseoSmile Crown plusSummary page 4…770) Regulatory Class: II Product Code: EBF, EBG Classification Panel: Dental V. PREDICATE DEVICE Primary Predicate Device: K201668, Tooth shade resin material / BEGO Bremer Goldschlägerei Wilh. Herbst GmbH… | 2020 |
| † | K193553 | VarseoSmile Temp | 2020 |
What descends from it? (13)
See all 135 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 17 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K213343 (Saremco Dental AG, 2022) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K201668.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces.
The TERA HARZ material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations.
Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202846 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202846: Tera Harz.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202846
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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