510(k) · Cleared
ClearedStarceram
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H.C. Starck Ceramics GmbH · EIH Powder, Porcelain
Cleared on Dec 5, 2013 as substantially equivalent to K081263 (H.C. Starck Ceramics GmbH & Co.Kg, 2008) and 1 other predicate after a 48-day review. Its family tree reaches back 7 generations to 1983. 3 later devices descend from it.
- Decided
- Dec 5, 2013
- Review
- 48 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K830955 (1983). 24 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 6 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 5 generations backK984201 DenzirDentronic AB · 1999
- 4 generations backK023327 Cynovad ZirkonCynovad · 2002
- 3 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 2 generations backK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- 1 generation backK081263 StarceramH.C. Starck Ceramics GmbH & Co.Kg · 2008
- This deviceK133213 StarceramH.C. Starck Ceramics GmbH · 2013
- Descendant · cites it directly · 1 of its ownK140924 StarceramH.C. Starck Ceramics GmbH · 2014
- Descendant · cites it directly · 0 of its ownK143656 StarCeram® Z-Nature, StarCeram® Z-SmileH.C. Starck Ceramics GmbH · 2015
- Descendant · cites it directly · 0 of its ownK143071 Nacera PearlDoceram Medical Ceramics GmbH · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −6 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −5 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −4 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −3 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −2 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| −1 | K081263 | Starceram | H.C. Starck Ceramics GmbH & Co.Kg | 2008 | — |
| 0 (this device) | K133213 | Starceram | H.C. Starck Ceramics GmbH | 2013 | — |
| +1 | K140924 | Starceram | H.C. Starck Ceramics GmbH | 2014 | — |
| +1 | K143656 | StarCeram® Z-Nature, StarCeram® Z-Smile | H.C. Starck Ceramics GmbH | 2015 | — |
| +1 | K143071 | Nacera Pearl | Doceram Medical Ceramics GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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 EIH? 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 EIH device
- #1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 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 |
|---|---|---|---|
| * | K081263 | StarceramSummary page 1…uther-Str. 81 95100 Selb, Germany Common or Usual Name Powder, Porcelain Classification Name 21 C.F.R. 872.6660 Predicate Devices StarCeram Z-Med and Z-AI-Med RD (K081263) ZENO Zr Disc (K112710) Intended Use / Indications for Use Dental Blanks made from StarCeram@ are indicated for… | 2008 |
| * | K112710 | Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZRSummary page 1…b, Germany Common or Usual Name Powder, Porcelain Classification Name 21 C.F.R. 872.6660 Predicate Devices StarCeram Z-Med and Z-AI-Med RD (K081263) ZENO Zr Disc (K112710) Intended Use / Indications for Use Dental Blanks made from StarCeram@ are indicated for crowns, multi-unit brid… | 2011 |
What descends from it? (3)
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 30 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K140924 (H.C. Starck Ceramics GmbH, 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K081263.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · EIH
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIH
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIH
1in 2025
MAUDE reports naming product code EIH, 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 | 15 | 63 | 0 | 0 |
| 2008 | 15 | 87 | 0 | 1 |
| 2009 | 15 | 79 | 0 | 0 |
| 2010 | 14 | 89 | 0 | 0 |
| 2011 | 14 | 80 | 0 | 1 |
| 2012 | 9 | 96 | 0 | 0 |
| 2013 | 16 | 107 | 0 | 6 |
| 2014 | 18 | 118 | 0 | 1 |
| 2015 | 23 | 118 | 0 | 0 |
| 2016 | 22 | 187 | 21 | 4 |
| 2017 | 16 | 149 | 0 | 1 |
| 2018 | 10 | 139 | 0 | 2 |
| 2019 | 16 | 125 | 0 | 1 |
| 2020 | 13 | 155 | 0 | 0 |
| 2021 | 17 | 131 | 0 | 22 |
| 2022 | 16 | 89 | 0 | 0 |
| 2023 | 15 | 114 | 0 | 0 |
| 2024 | 28 | 89 | 0 | 7 |
| 2025 | 13 | 84 | 1 | 1 |
| 2026 | 14 | 73 | 0 | — |
What is it indicated for?
Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133213: Starceram.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133213
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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