510(k) · Cleared
ClearedNexxzr (TM)T and Nexxzr (TM)S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sagemax Bioceramics, Inc. · EIH Powder, Porcelain
Cleared on Feb 10, 2014 as substantially equivalent to K062695 (Sagemax Bioceramics, Inc., 2006) after a 306-day review. Its family tree reaches back 6 generations to 1983. 7 later devices descend from it.
- Decided
- Feb 10, 2014
- Review
- 306 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K830955 (1983). 14 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 5 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 4 generations backK984201 DenzirDentronic AB · 1999
- 3 generations backK023327 Cynovad ZirkonCynovad · 2002
- 2 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 1 generation backK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- This deviceK130991 Nexxzr (TM)T and Nexxzr (TM)SSagemax Bioceramics, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK230873 Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK222469 TIB AbutmentsSouthern Implants (Pty), Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK222457 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK210884 1Derful HS, 1Derful HT1derful, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · cites it directly3descendants
- K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd. · 2023 · 2 generations on0descendants
- K222469TIB AbutmentsSouthern Implants (Pty), Ltd. · 2023 · 2 generations on0descendants
- K222457Provata Implant SystemSouthern Implants (Pty), Ltd. · 2023 · 2 generations on0descendants
- K2108841Derful HS, 1Derful HT1derful, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −5 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −4 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −3 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −2 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −1 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| 0 (this device) | K130991 | Nexxzr (TM)T and Nexxzr (TM)S | Sagemax Bioceramics, Inc. | 2014 | — |
| +1 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +2 | K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments | Southern Implants (Pty), Ltd. | 2023 | — |
| +2 | K222469 | TIB Abutments | Southern Implants (Pty), Ltd. | 2023 | — |
| +2 | K222457 | Provata Implant System | Southern Implants (Pty), Ltd. | 2023 | — |
| +1 | K210884 | 1Derful HS, 1Derful HT | 1derful, Inc. | 2021 | — |
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 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 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? (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 |
|---|---|---|---|
| * | K062695 | Sagemax Z-BlankSummary page 1…ous version, Sagemax Z-BlankWM. VIII. Substantial Equivalence: Sagemax NexxZrm materials are substantially equivalent to our current, legally marketed device, K062695, Sagemax 7-Blanks; they are intended for the same purpose, namely to fabricate crowns (temporary or permanent)… | 2006 |
What descends from it? (7)
4 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 31 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K193084 (Southern Implants (Pty), Ltd., 2020) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K062695.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
NexxZr T and NexxZr S are intended for the fabrication and preparation of copings and full anatomical/full contour crowns, bridges, inlays and onlays for anterior and posterior segment restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130991: Nexxzr (TM)T and Nexxzr (TM)S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130991
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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