510(k) · Cleared
ClearedKATANA Zirconia ONE For IMPLANT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Noritake Dental, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 24, 2024 as substantially equivalent to K193408 (Dentsply Sirona, 2020) after a 238-day review. Its family tree reaches back 13 generations to 1990.
- Decided
- May 24, 2024
- Review
- 238 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K894844 (1990). 122 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 9 generations between
- 3 generations backK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- 2 generations backK181520 Sirona Dental CAD/CAM SystemDentsply Sirona · 2018
- 1 generation backK193408 Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona · 2020
- This deviceK233285 KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 12 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 11 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 10 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 9 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 8 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 7 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 6 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 5 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 4 generations backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- 3 generations backK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- 2 generations backK181520 Sirona Dental CAD/CAM SystemDentsply Sirona · 2018
- 1 generation backK193408 Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona · 2020
- This deviceK233285 KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −12 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −11 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −10 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −9 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −8 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −7 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −6 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −5 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −4 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| −3 | K111421 | Sirona Dental Cad/Cam System | Sirona Dental Systems GmbH | 2012 | — |
| −2 | K181520 | Sirona Dental CAD/CAM System | Dentsply Sirona | 2018 | — |
| −1 | K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software | Dentsply Sirona | 2020 | — |
| 0 (this device) | K233285 | KATANA Zirconia ONE For IMPLANT | Kuraray Noritake Dental, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 8 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 10 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.7 · 19 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 |
|---|---|---|---|
| * | K193408 | Sirona Dental CAD/CAM System with CEREC Chairside SoftwareSummary page 6…3-1. Primary predicate device 1) Trade / Proprietary name Sirona Dental CAD/CAM System with CEREC Chairside software 2) 510(k) number K193408 3) Classification name Abutment, Implant, Dental, Endosseous (21 CFR sec… | 2020 |
| † | K200191 | Sirona Dental CAD/CAM System with InLab Software | 2020 |
| † | K190436 | KATANA Zirconia Block | 2019 |
| † | K191382 | IPS e.max CAD Abutment Solutions- extra systems | 2019 |
| † | K183537 | PANAVIA SA Cement Universal | 2019 |
| † | K181520 | Sirona Dental CAD/CAM System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 16 of the 122 ancestors have a recall of any class.
- 1 other device also cites its predicate K193408.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
KATANA Zirconia ONE For IMPLANT is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. For the SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. KATANA Zirconia ONE For IMPLANT is used in combination with the TiBase and Sirona Dental CAD/CAM System. KATANA Zirconia ONE…
Read the full statement (107 words)
KATANA Zirconia ONE For IMPLANT is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.
For the SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.
KATANA Zirconia ONE For IMPLANT is used in combination with the TiBase and Sirona Dental CAD/CAM System. KATANA Zirconia ONE For IMPLANT cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.
Compatible implant systems and TiBase are as follows.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233285 · printed Nov 3, 2026
Cite this page
510(k) Report. “K233285: KATANA Zirconia ONE For IMPLANT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K233285
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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