510(k) · Cleared
ClearedSirona Dental Cad/Cam System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 17, 2012 as substantially equivalent to K091756 (Nobel Biocare AB, 2009) and 9 other predicates after a 273-day review. Its family tree reaches back 10 generations to 1990. 54 later devices descend from it.
- Decided
- Feb 17, 2012
- Review
- 273 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 10 generations to K894844 (1990). 119 ancestors in all, the oldest K871863 (1987). 54 later devices descend from it, 7 citing it directly.
- Root · 10 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 6 generations between
- 3 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 2 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 1 generation backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- This deviceK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- Descendant · cites it directly · 39 of its ownK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
- Descendant · 2 generations on · 30 of its ownK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
- Descendant · 3 generations on · 13 of its ownK151324 Straumann Variobase for CERECStraumann USA, LLC · 2015
- Descendant · 4 generations on · 7 of its ownK171532 TruBase STruabutment, Inc. · 2018
- Descendant · 5 generations on · 6 of its ownK201197 TruAbutment DS, TruBase STruabutment, Inc. · 2021
Show all 10 generations
- Root · 10 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 9 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 8 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 7 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 6 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 5 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 4 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 3 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 2 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 1 generation backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- This deviceK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013 · cites it directly39descendants
- K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC · 2015 · 2 generations on30descendants
- K151324Straumann Variobase for CERECStraumann USA, LLC · 2015 · 3 generations on13descendants
- K171532TruBase STruabutment, Inc. · 2018 · 4 generations on7descendants
- K201197TruAbutment DS, TruBase STruabutment, Inc. · 2021 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −9 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −8 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −7 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −6 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −5 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −4 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −3 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −2 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −1 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| 0 (this device) | K111421 | Sirona Dental Cad/Cam System | Sirona Dental Systems GmbH | 2012 | — |
| +1 | K132209 | Ips E.Max Cad Abutment Solutions | Ivoclar Vivadent, AG | 2013 | — |
| +2 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann… | Straumann USA, LLC | 2015 | — |
| +3 | K151324 | Straumann Variobase for CEREC | Straumann USA, LLC | 2015 | — |
| +4 | K171532 | TruBase S | Truabutment, Inc. | 2018 | — |
| +5 | K201197 | TruAbutment DS, TruBase S | Truabutment, Inc. | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 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? (10)
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 |
|---|---|---|---|
| * | K091756 | Nobelprocera TI AbutmentSummary page 1…n/Usual Name: Abutment, implant, dental, endosseous Classification Names: Endosseous dental implant abutment 3 Predicate Devices Replace® NP, K091756, Brhnemark®, K091756, Tissue level NN, K081005, OsseoSpeed Tm , K081666, Frialit® / Xiveg, K032158, Osseotite K072642, Tape… | 2009 |
| * | K081005 | P.004 NC Cares Titanium and Ceramic AbutmentsSummary page 1…endosseous Classification Names: Endosseous dental implant abutment 3 Predicate Devices Replace® NP, K091756, Brhnemark®, K091756, Tissue level NN, K081005, OsseoSpeed Tm , K081666, Frialit® / Xiveg, K032158, Osseotite K072642, Tapered Screw-Vent®, K060880, Nobel Active NP… | 2008 |
| * | K081666 | Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 ImplantsSummary page 1…n Names: Endosseous dental implant abutment 3 Predicate Devices Replace® NP, K091756, Brhnemark®, K091756, Tissue level NN, K081005, OsseoSpeed Tm , K081666, Frialit® / Xiveg, K032158, Osseotite K072642, Tapered Screw-Vent®, K060880, Nobel Active NP, K102436, Bone Level NC, K0621… | 2008 |
| * | K032158 | Xive Dental Implant System MultipleSummary page 1…al implant abutment 3 Predicate Devices Replace® NP, K091756, Brhnemark®, K091756, Tissue level NN, K081005, OsseoSpeed Tm , K081666, Frialit® / Xiveg, K032158, Osseotite K072642, Tapered Screw-Vent®, K060880, Nobel Active NP, K102436, Bone Level NC, K062129, Certain@, K073345… | 2003 |
| * | K072642 | Biomet 3I Dental Abutments and Restorative ComponentsSummary page 1…3 Predicate Devices Replace® NP, K091756, Brhnemark®, K091756, Tissue level NN, K081005, OsseoSpeed Tm , K081666, Frialit® / Xiveg, K032158, Osseotite K072642, Tapered Screw-Vent®, K060880, Nobel Active NP, K102436, Bone Level NC, K062129, Certain@, K073345. Sirona Den… | 2007 |
| * | K060880 | Zimmer Dental One Piece Tapered Abutment, Models TAC1, TACW1, TA5C1Summary page 1…lace® NP, K091756, Brhnemark®, K091756, Tissue level NN, K081005, OsseoSpeed Tm , K081666, Frialit® / Xiveg, K032158, Osseotite K072642, Tapered Screw-Vent®, K060880, Nobel Active NP, K102436, Bone Level NC, K062129, Certain@, K073345. Sirona Dental CAD/CAM System (KI 00152) Sir… | 2006 |
| * | K102436 | Nobel Active 3.0Summary page 1…rk®, K091756, Tissue level NN, K081005, OsseoSpeed Tm , K081666, Frialit® / Xiveg, K032158, Osseotite K072642, Tapered Screw-Vent®, K060880, Nobel Active NP, K102436, Bone Level NC, K062129, Certain@, K073345. Sirona Dental CAD/CAM System (KI 00152) Sirona Dental 510(k) Summary… | 2010 |
| * | K062129 | P.0004 ImplantsSummary page 1…el NN, K081005, OsseoSpeed Tm , K081666, Frialit® / Xiveg, K032158, Osseotite K072642, Tapered Screw-Vent®, K060880, Nobel Active NP, K102436, Bone Level NC, K062129, Certain@, K073345. Sirona Dental CAD/CAM System (KI 00152) Sirona Dental 510(k) Summary May 06, 20… | 2006 |
| * | K073345 | Certain Contoured Margin Ceramic AbutmentSummary page 1…eoSpeed Tm , K081666, Frialit® / Xiveg, K032158, Osseotite K072642, Tapered Screw-Vent®, K060880, Nobel Active NP, K102436, Bone Level NC, K062129, Certain@, K073345. Sirona Dental CAD/CAM System (KI 00152) Sirona Dental 510(k) Summary May 06, 2011 Sirona Dental CAD/CAM… | 2008 |
| * | K100152 | Sirona Cad/Cam SystemSummary page 12…ffer in that proposed devices have an additional notch. An extensive list is provided in Table 5. 6.2 inCoris ZI meso Proposed and predicate (K100152) device are inCoris ZI mesa. Sirona Dental 5 10O(k) Summary May 06, 2011 Sirona Dental CAD/CAM System… | 2010 |
What descends from it? (54)
See all 547 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 22 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 16 of the 119 ancestors have a recall of any class.
- Of its descendants, K132209 (Ivoclar Vivadent, AG, 2013) has gone furthest, with 39 descendants of its own.
- 9 other devices also cite its predicate K091756.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. The system consists of three major parts: TiBase, InCoris mesostructure, and CAD/CAM software. Specifically, the InCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and…
Read the full statement (167 words)
The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. The system consists of three major parts: TiBase, InCoris mesostructure, and CAD/CAM software. Specifically, the InCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The InCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the InCoris mesostructure. The InCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems:
* Nobel Biocare Replace (K020646)
* Nobel Biocare Branemark (K022562)
* Friadent Xive (K013867)
* Biomet 3i Osseotite (K980549)
* Astra Tech Osseospeed (K091239)
* Zimmer Tapered Screw-Vent (K061410)
* Straumann SynOcta (K061176)
* Straumann Bone Level (K053088)
* Biomet 3i Certain (K014235)
* Nobel Biocare Active (K071370)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111421: Sirona Dental Cad/Cam System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111421
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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