510(k) · Cleared
ClearedCEREC Tessera Abutment Block, CEREC Tessera Abutment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 22, 2023 as substantially equivalent to K191382 (Ivoclar Vivadent, AG, 2019) after a 310-day review. Its family tree reaches back 13 generations to 1990. 2 later devices descend from it.
- Decided
- Mar 22, 2023
- Review
- 310 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K894844 (1990). 125 ancestors in all, the oldest K871863 (1987). 2 later devices descend from it, 2 citing it directly.
- 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 backK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
- 1 generation backK191382 IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG · 2019
- This deviceK221402 CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK252248 CEREC Tessera Abutment SystemDentsply Sirona · 2025
- Descendant · cites it directly · 0 of its ownK234018 CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona · 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 backK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
- 1 generation backK191382 IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG · 2019
- This deviceK221402 CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView 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 | K132209 | Ips E.Max Cad Abutment Solutions | Ivoclar Vivadent, AG | 2013 | — |
| −1 | K191382 | IPS e.max CAD Abutment Solutions- extra systems | Ivoclar Vivadent, AG | 2019 | — |
| 0 (this device) | K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System | Dentsply Sirona, Inc. | 2023 | — |
| +1 | K252248 | CEREC Tessera Abutment System | Dentsply Sirona | 2025 | — |
| +1 | K234018 | CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System | Dentsply Sirona | 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 | 4 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K191382 | IPS e.max CAD Abutment Solutions- extra systemsSummary page 6…ices are noted below: Predicate Device: Primary Predicate Device Name 510(k) Company Name IPS e.max® CAD Abutment Solution K191382 Ivoclar Vivadent AG extra systems Reference Devices: Reference Device Name… | 2019 |
| † | K161269 | CELTRA Press | 2016 |
| † | K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software | 2020 |
| † | K200191 | Sirona Dental CAD/CAM System with InLab Software | 2020 |
What descends from it? (2)
2 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 33 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 17 of the 125 ancestors have a recall of any class.
- Of its descendants, K252248 (Dentsply Sirona, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
CEREC Tessera Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts: - CEREC Tessera Abutment Block - TiBase - CAD/CAM system. The CEREC Tessera ceramic structure 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…
Read the full statement (129 words)
CEREC Tessera Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.
The system comprises three parts:
- CEREC Tessera Abutment Block
- TiBase
- CAD/CAM system.
The CEREC Tessera ceramic structure 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.
The compatible Implant systems, titanium bases and CAD/CAM systems are shown below:
Implant Systems:
- Dentsply Sirona: AstraTech OsseoSpeed TX (K053384), XiVE (K013867), AstraTech Implant EV (K120414), Ankylos (K083805), PrimeTaper EV (K210610)
- MIS: C1 Conical connection (K172505 NP, K180282 WP), V3 Conical connection (K163349), SEVEN internal hex (K112162), M4 internal hex (K112162)
CAD/CAM Systems:
- Sirona Dental CAD/CAM System (K193408, K200191)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221402 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221402: CEREC Tessera Abutment Block, CEREC Tessera Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221402
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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