510(k) · Cleared
ClearedDDS-ZR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Charles Scharf · EIH Powder, Porcelain
Cleared on Jul 9, 2004 as substantially equivalent to K013230 (Degussa - Ney Dental, Inc., 2001) and 2 other predicates after a 22-day review. Its family tree reaches back 4 generations to 1983. 8 later devices descend from it.
- Decided
- Jul 9, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K830955 (1983). 11 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 3 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 2 generations backK984201 DenzirDentronic AB · 1999
- 1 generation backK023327 Cynovad ZirkonCynovad · 2002
- This deviceK041645 DDS-ZRCharles Scharf · 2004
- Descendant · cites it directly · 7 of its ownK072241 Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK103339 TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd. · 2011
- Descendant · 2 generations on · 2 of its ownK110778 Biodenta Customized AbutmentBiodenta Swiss AG · 2011
- Descendant · 3 generations on · 1 of its ownK151295 Biodenta Customized Abutment - TitaniumBiodenta Swiss AG · 2015
- Descendant · 4 generations on · 0 of its ownK231210 DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007 · cites it directly7descendants
- K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd. · 2011 · 2 generations on3descendants
- K110778Biodenta Customized AbutmentBiodenta Swiss AG · 2011 · 2 generations on2descendants
- K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG · 2015 · 3 generations on1descendant
- K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −3 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −2 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −1 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| 0 (this device) | K041645 | DDS-ZR | Charles Scharf | 2004 | — |
| +1 | K072241 | Primaconnex Cad/Cam Abutment System | Lifecore Biomedical, Inc. | 2007 | — |
| +2 | K103339 | TDS Abutment for Friadent Xive | Pou YU Biotechnology Co., Ltd. | 2011 | — |
| +2 | K110778 | Biodenta Customized Abutment | Biodenta Swiss AG | 2011 | — |
| +3 | K151295 | Biodenta Customized Abutment - Titanium | Biodenta Swiss AG | 2015 | — |
| +4 | K231210 | DGA Abutment | Modern Dental Laboratory (Dg) Co., Ltd. | 2024 | — |
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 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2024 | 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 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? (3)
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 |
|---|---|---|---|
| * | K013230 | Cercon BaseSummary page 1…visualization. VII. Substantial equivalence: Similar to devices currently on the market approved through the 510K process. DDS-ZR is similar to Cercon K-013230, Cynovad Zirkon K023327, and Denzir K984201. The 510OK "Substantial equivalence" decision-making process (deta… | 2001 |
| * | K023327 | Cynovad ZirkonSummary page 1…tial equivalence: Similar to devices currently on the market approved through the 510K process. DDS-ZR is similar to Cercon K-013230, Cynovad Zirkon K023327, and Denzir K984201. The 510OK "Substantial equivalence" decision-making process (detailed) from ODE Guidance… | 2002 |
| * | K984201 | DenzirSummary page 1…Similar to devices currently on the market approved through the 510K process. DDS-ZR is similar to Cercon K-013230, Cynovad Zirkon K023327, and Denzir K984201. The 510OK "Substantial equivalence" decision-making process (detailed) from ODE Guidance Memorandum #86-3 was… | 1999 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072241 | Primaconnex Cad/Cam Abutment System | 2007 | 7 |
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 21 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K072241 (Lifecore Biomedical, Inc., 2007) has gone furthest, with 7 descendants of its own.
- 14 other devices also cite its predicate K013230.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, V (Inlays and Onlays) and restorative material intended for veneers, crowns, and bridges
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041645: DDS-ZR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041645
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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