510(k) · Cleared
ClearedTera Harz II
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 Nov 1, 2023 as substantially equivalent to K202846 (Graphy, Inc., 2021) after a 1-day review. Its family tree reaches back 8 generations to 2004. 1 later device descends from it.
- Decided
- Nov 1, 2023
- Review
- 1 day
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K042819 (2004). 15 ancestors in all, the oldest K920425 (1992). 1 later device descends from it, 1 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 deviceK233502 Tera Harz IIGraphy, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK250763 ReonC.E.I.B.Med · 2025
Most influential descendants
Showing 1 of 1 · See all- K250763ReonC.E.I.B.Med · 2025 · 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) | K233502 | Tera Harz II | Graphy, Inc. | 2023 | — |
| +1 | K250763 | Reon | C.E.I.B.Med | 2025 | — |
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 |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K202846 | Tera HarzSummary page 4…) Regulatory Class: II Product Code: EBF, EBG Classification Panel: Dental V. PREDICATE DEVICE Primary Predicate Device: K202846, TERA HARZ / Graphy Inc. (Class II) Referencee Device K222414, TERA HARZ DENTURE / Graphy Inc. (Class II) VI. DEVICE DESCR… | 2021 |
| † | K222414 | Tera Harz Denture | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250763 | Reon | 2025 | 0 |
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 19 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K250763 (C.E.I.B.Med, 2025) has gone furthest, with 0 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. 2023, 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 II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II 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 II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer…
Read the full statement (110 words)
TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces.
The TERA HARZ II 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 II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Brand Type
Design : 3 Shape A/S TRIOS 3 Basic
Instraoral scanner 3 Shape A/S 3Shape dental system
Design software
Additive Manufacturing system :
3D Printer UNIZ NBEE
SprintRay Inc. Pro 95
Post-Curing :
Post-cure unit CureM U102H
TERA HARZ CURE THC
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/K233502 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233502: Tera Harz II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233502
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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