510(k) · Cleared
ClearedCEREC Tessera Abutment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 26, 2025 as substantially equivalent to K221402 (Dentsply Sirona, Inc., 2023) after a 131-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Nov 26, 2025
- Review
- 131 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K894844 (1990). 126 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 14 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 10 generations between
- 3 generations backK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
- 2 generations backK191382 IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG · 2019
- 1 generation backK221402 CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc. · 2023
- This deviceK252248 CEREC Tessera Abutment SystemDentsply Sirona · 2025
Show all 14 generations
- Root · 14 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 13 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 12 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 11 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 10 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 9 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 8 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 7 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 6 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 5 generations backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- 4 generations backK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- 3 generations backK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
- 2 generations backK191382 IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG · 2019
- 1 generation backK221402 CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc. · 2023
- This deviceK252248 CEREC Tessera Abutment SystemDentsply Sirona · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −13 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −12 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −11 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −10 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −9 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −8 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −7 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −6 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −5 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| −4 | K111421 | Sirona Dental Cad/Cam System | Sirona Dental Systems GmbH | 2012 | — |
| −3 | K132209 | Ips E.Max Cad Abutment Solutions | Ivoclar Vivadent, AG | 2013 | — |
| −2 | K191382 | IPS e.max CAD Abutment Solutions- extra systems | Ivoclar Vivadent, AG | 2019 | — |
| −1 | K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System | Dentsply Sirona, Inc. | 2023 | — |
| 0 (this device) | K252248 | CEREC Tessera Abutment System | Dentsply Sirona | 2025 | — |
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 |
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 30.6 · 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 |
|---|---|---|---|
| * | K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemSummary page 8…: Predicate Device: Primary Predicate Device Name 510(k) Company Name CEREC Tessera Abutment Block, K221402 Dentsply Sirona CEREC Tessera Abutment System Reference Devices in support for fatigue testing:… | 2023 |
| † | K234018 | CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System | 2024 |
| † | K250295 | Dentsply Sirona Titanium Bases system | 2025 |
| † | K111421 | Sirona Dental Cad/Cam System | 2012 |
| † | K143022 | BioHorizons Tapered Internal Implants | 2015 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K093321 | Biohorizons Laser-Lok 3.0 Implant System | 2010 |
| † | K042429 | The Prodigy System Dental Implants | 2004 |
| † | K020646 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102… | 2002 |
| † | K071370 | Nobelactive Internal Connection Implant | 2007 |
| † | K022562 | Various Branemark System Implants-Immediate Function Indication | 2002 |
| † | K151324 | Straumann Variobase for CEREC | 2015 |
| † | K192742 | Straumann Variobase C | 2021 |
| † | K093615 | Spi Dental Implant, Element | 2010 |
| † | K090154 | Spi Dental Implant Inicell | 2009 |
| † | K121585 | TS Implant System | 2013 |
| † | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… | 2006 |
| † | K061629 | Certain Prevail Dental Implant | 2007 |
| † | K014235 | Osseotite NT Dental Implants & Accessories | 2002 |
| † | K083496 | Camlog Implant System Modified Implants and Abutments | 2009 |
| † | K191152 | MIS Ti-base Abutment | 2020 |
| † | K200191 | Sirona Dental CAD/CAM System with InLab Software | 2020 |
| † | K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software | 2020 |
| † | K181520 | Sirona Dental CAD/CAM System | 2018 |
| † | K100152 | Sirona Cad/Cam System | 2010 |
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 35 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 17 of the 126 ancestors have a recall of any class.
- 1 other device also cites its predicate K221402.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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. For BH 3.0 S, NC Variobase C 3.3, Camlog 3.3 S and S BL 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. The system comprises three parts: - CEREC Tessera Abutment Block - TiBase - CAD/CAM…
Read the full statement (1,121 words)
CEREC Tessera Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.
For BH 3.0 S, NC Variobase C 3.3, Camlog 3.3 S and S BL 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.
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 Siron a: AstraTech OsseoSpeed TX, Ankylos
- BioHorizons: Internal connection
- Nobel Biocare: Replace, Replace Select, Nobel Active, NobelReplace Concial Connection, Branemark,
NobelSpeedy Groovy
- Straumann: Tissue Level, Bone Level
- Thommen Medical: Element, Contact
- Osstem/Hiossen: Osstem TS, (USA:Hiossen ET)
- Zimmer/Biomet: External hex , Certain, Tapered Screw-Vent
- MIS: C1 Conical connection, V3 Conical connection, SEVEN internal hex, M4 internal hex
- Altatec - Camlog
- MIS: C1 Conical connection (NP and WP), V3 Conical connection, SEVEN internal hex, M4 internal hex
CAD/CAM Systems:
-Sirona Dental CAD/CAM System
Titanium Bases:
Implant: AstraTech Osseospeed TX
Platform: 3.5/4.0; TiBase AT TX 3.5/4.0 GH1 L; Reference 6598093; Size L
Platform: 4.5/5.0; TiBase AT TX 4.5/5.0 GH1 L; Reference 6598101; Size L
Platform: 3.5/4.0; TiBase AT OS 3.5/4.0 GH1 L; Reference 6282532; Size L
Platform: 4.5/5.0; TiBase ATOS 4.5/5.0 GH1 L; Reference 6282540; Size L
Implant: Ankylos
Platform: C/X; TiBase ANK C/ GH 1 S; Reference 6586528; Size: S
Platform: C/X; TiBase ANK C/ GH 2 S; Reference 6586536; Size: S
Platform: C/X; TiBase ANK /X GH 2 S; Reference 6586551; Size: S
Manufacturer: M.I.S. Implants
Implant: C1 Conical Connection
Platform: NP; CN-TB001 C1 NP GH 0.5; Reference CN-TB001; Size: L
Platform: NP; CN-B015 C1 NP GH 1.5; Reference CN-TB015; Size: L
Implant: V3 Conical Connection
Platform: NP; VN-TB001 V3 NP GH 0.5; Reference VN-TB001 ; Size: L
Platform: NP; VN-TB015 V3 NP GH 1.5; Reference VN-TB015; Size: L
Implant: V3 Conical Connection / C1 Conical Connection
Platform: SP; CS-TB001 SP GH 0.5; Reference CS-TB001; Size: L
Platform: SP; CS-TB015 SP GH 1.5; Reference CS-TB015; Size: L
Platform: SP; CS-TB030 SP GH 3; Reference CS-TB030; Size: L
Implant: C1 Conical Connection
Platform: WP; CW-TB001 C1 WP GH 0.5; Reference CW-TB001 ; Size: L
Platform: WP; CW-TB015 C1 WP GH 1.5; Reference CW-TB015; Size: L
Platform: WP; CW-TB030 C1 WP GH 3; Reference CW-TB030; Size: L
Implant: SEVEN internal hex, M4 internal hex
Platform: NP; MN-TB001 INT HEX NP GH 0.5; Reference MN-TB001 ; Size: L
Platform: NP; MN-TBC15 INT HEX NP GH 1.5; Reference MN-TBC15; Size: L
Platform: SP; MD-TB001 INT HEX SP GH 0.5; Reference MD-TB001 ; Size: L
Platform: SP; MD-TBC15 INT HEX SP GH 1.5; Reference MD-TBC15; Size: L
Platform: SP; MD-TBC30 INT HEX SP GH 3; Reference MD-TBC30; Size: L
Platform: WP; MW-TB001 INT HEX WP GH 0.5; Reference MW-TB001 ; Size: L
Platform: WP; MW-TBC15 INT HEX WP GH 1.5; Reference: MW-TBC15; Size: L
Platform: WP; MW-TBC30 INT HEX WP GH 3; Reference: MW-TBC30; Size: L
Manufacturer: BioHorizons
Implant: Internal Connection
Platform: 3.0; TiBase BH 3.0 GH 1 S; Reference 6532779; Size: S
Platform: 3.5; TiBase BH 3.5 GH 1 L; Reference 6532894; Size: L
Platform: 4.5; TiBase BH 4.5 GH 1 L; Reference 6532951; Size: L
Platform: 5.7; TiBase BH 5.7 GH 1 L; Reference 6536242; Size: L
Manufacturer: Nobel Biocare
Implant: Replace, Replace Select
Platform: NP; TiBase NB RS 3.5 GH 1 L; Reference 6282474; Size: L
Platform: RP; TiBase NB RS 4.3 GH 1 L; Reference 6282482; Size: L
Platform: WP; TiBase NB RS 5.0 GH 1 L; Reference 6282490; Size: L
Platform: 6.0; TiBase NB RS 6.0 GH 1 L; Reference 6282508; Size: L
Implant: Nobel Active, Nobel Replace Conical Connection
Platform: NP; TiBase NB A 4.5 GH 1 L; Reference 6308188; Size: L
Platform: RP; TiBase NB A 5.0 GH 1 L; Reference 6308253; Size: L
Implant: Branemark
Platform: NP; TiBase NB B 3.4 GH 1 L; Reference 6282516; Size: L
Implant: NobelSpeedy Groovy
Platform: RP; TiBase NB B 4.1 GH 1 L; Reference 6282524; Size: L
Manufacturer: Straumann
Implant: Tissue Level
Platform: RN (4.8 mm); TiBase SSO 4.8 GH 1 L; Reference 6284249; Size: L
Platform: WN (6.5 mm); TiBase SSO 6.5 GH 1 L; Reference 6284256; Size: L
Implant: Bone Level
Platform: NC (3.3 mm); TiBase S BL 3.3 GH 1 L; Reference 6308154; Size: L
Platform: RC (4.1 mm/ 4.8 mm); TiBase S BL C 4.1 GH 1 L; Reference 6308337; Size: L
Manufacturer: Thommen Medical
Implant: Element, Contact
Platform: 3.5; TiBase TM 3.5 GH 1 S; Reference 6531854; Size: S
Platform: 4; TiBase TM 4 GH 1 S; Reference 6532829; Size: S
Platform: 4.5; TiBase TM 4.5 GH 1 S; Reference 6532837; Size: S
Platform: 5; TiBase TM 5 GH 1 S; Reference 6544360; Size: S
Platform: 6; TiBase TM 6 GH 1 S; Reference 6544378; Size: S
Manufacturer: Osstem / Hiossen
Implant: Osstem TS (US Hiossen ET)
Platform: Mini; TiBase O TS 3.5 GH 1 L; Reference 6527035; Size: L
Platform: Regular; TiBase O TS 4.0 GH 1 L; Reference 6527043; Size: L
Manufacturer: Zimmer / Biomet
Implant: External hex
Platform: 3.4; TiBase BO 3.4 GH 1 L; Reference 6282557; Size: L
Platform: 4.1; TiBase BO 4.1 GH 1 L; Reference 6282565; Size: L
Platform: 5.0; TiBase BO 5.0 GH 1 L; Reference 6282573; Size: L
Implant: Certain
Platform: 3.4; TiBase B C 3.4 GH 1 S; Reference 6308048; Size: S
Platform: 4.1; TiBase BC 4.1 GH 1 L; Reference 6308097; Size: L
Platform: 5.0; TiBase BC 5.0 GH 1 L; Reference 6308121; Size: L
Implant: Tapere d Screw-Vent
Platform: 3.5; TiBase Z TSV 3.5 GH 1 L; Reference 6282581; Size: L
Platform: 4.5; TiBase Z TSV 4.5 GH 1 L; Reference 6282599; Size: L
Platform: 5.7; TiBase Z TSV 5.7 GH 1 L; Reference 6282607; Size: L
Manufacturer: Straumann
Implant: Bone Level
Platform: NC (3.3 mm); TiBase NC Variobase C 3.3 GH 1; Reference 220.043; Size: S
Platform: RC (4.1 mm/ 4.8 mm); TiBase RC Variobase C 4.1 GH 1; Reference 220.044; Size: L
Manufacturer: Altatec GmbH-Camlog
Implant: Camlog
Platform: 3.3; CAMLOG Titanium Base CAD/CAM, for 0 3.3 mm GH 0.4; Refere nce K2244.3348; Size S
Platform: 3.8; CAMLOG Titanium Base CAD/CAM, for 0 3.8 mm GH 0.3; Reference K2244.3848; Size: S
Platform: 4.3; CAMLOG Titanium Base CAD/CAM, for 0 4.3 mm GH 0.3; Reference K2244.4348; Size: S
Platform: 6.0; CAMLOG Titanium Base CAD/CAM, for 0 6.0 mm GH 0.3; Reference 1<2244.6048; Size: L
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252248: CEREC Tessera Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252248
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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