510(k) · Cleared
ClearedSirona 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 Oct 22, 2010 as substantially equivalent to K091756 (Nobel Biocare AB, 2009) and 7 other predicates after a 276-day review. Its family tree reaches back 9 generations to 1990. 240 later devices descend from it.
- Decided
- Oct 22, 2010
- Review
- 276 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 9 generations to K894844 (1990). 115 ancestors in all, the oldest K871863 (1987). 240 later devices descend from it, 5 citing it directly.
- Root · 9 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations between
- 3 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 2 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 1 generation backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- This deviceK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- Descendant · cites it directly · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 2 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · 2 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · cites it directly · 54 of its ownK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
Show all 9 generations
- Root · 9 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 8 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 7 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 6 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 5 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 4 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 3 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 2 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 1 generation backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- This deviceK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
Showing 5 of 240 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 240 · See all- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · cites it directly165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 2 generations on129descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 2 generations on89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 3 generations on86descendants
- K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012 · cites it directly54descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −8 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −7 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −6 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −5 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −4 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −3 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −2 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −1 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| 0 (this device) | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| +1 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +2 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +2 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +1 | K111421 | Sirona Dental Cad/Cam System | Sirona Dental Systems GmbH | 2012 | — |
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 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 7 | 0 |
| 2015 | 11 | 0 |
| 2016 | 12 | 0 |
| 2017 | 10 | 0 |
| 2018 | 13 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 22 | 0 |
| 2022 | 19 | 0 |
| 2023 | 31 | 0 |
| 2024 | 34 | 0 |
| 2025 | 27 | 0 |
| 2026 | 14 | 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? (8)
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…dental, endosseous Classification Names: Endosseous dental implant abutment 3 Predicate Devices Replace®&NP, K0917'56, Br~nemnark®I, K091756, Tissue level NIN, K081005, OsseoSpeedrm, K081666, Frialit® / Xive®), K032158, Osseotite K072642, Tapered S… | 2009 |
| * | K081005 | P.004 NC Cares Titanium and Ceramic AbutmentsSummary page 1…Classification Names: Endosseous dental implant abutment 3 Predicate Devices Replace®&NP, K0917'56, Br~nemnark®I, K091756, Tissue level NIN, K081005, OsseoSpeedrm, K081666, Frialit® / Xive®), K032158, Osseotite K072642, Tapered Screw-Vent®, K060880.… | 2008 |
| * | K081666 | Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 ImplantsSummary page 1…seous dental implant abutment 3 Predicate Devices Replace®&NP, K0917'56, Br~nemnark®I, K091756, Tissue level NIN, K081005, OsseoSpeedrm, K081666, Frialit® / Xive®), K032158, Osseotite K072642, Tapered Screw-Vent®, K060880. Zirconium oxide sleeve for C… | 2008 |
| * | K032158 | Xive Dental Implant System MultipleSummary page 1…t 3 Predicate Devices Replace®&NP, K0917'56, Br~nemnark®I, K091756, Tissue level NIN, K081005, OsseoSpeedrm, K081666, Frialit® / Xive®), K032158, Osseotite K072642, Tapered Screw-Vent®, K060880. Zirconium oxide sleeve for Camlog titanium bases (K03244… | 2003 |
| * | K072642 | Biomet 3I Dental Abutments and Restorative ComponentsSummary page 1…cate Devices Replace®&NP, K0917'56, Br~nemnark®I, K091756, Tissue level NIN, K081005, OsseoSpeedrm, K081666, Frialit® / Xive®), K032158, Osseotite K072642, Tapered Screw-Vent®, K060880. Zirconium oxide sleeve for Camlog titanium bases (K032448). Lav… | 2007 |
| * | K060880 | Zimmer Dental One Piece Tapered Abutment, Models TAC1, TACW1, TA5C1Summary page 1…17'56, Br~nemnark®I, K091756, Tissue level NIN, K081005, OsseoSpeedrm, K081666, Frialit® / Xive®), K032158, Osseotite K072642, Tapered Screw-Vent®, K060880. Zirconium oxide sleeve for Camlog titanium bases (K032448). Lava Software (K062493). Sirona Denta… | 2006 |
| * | K032448 | Altatec Ceramic AbutmentSummary page 1…eoSpeedrm, K081666, Frialit® / Xive®), K032158, Osseotite K072642, Tapered Screw-Vent®, K060880. Zirconium oxide sleeve for Camlog titanium bases (K032448). Lava Software (K062493). Sirona Dental 510(k) Summary October 20, 201 0 Sirona Dental CAD/… | 2003 |
| * | K062493 | Lava SoftwareSummary page 1…, K032158, Osseotite K072642, Tapered Screw-Vent®, K060880. Zirconium oxide sleeve for Camlog titanium bases (K032448). Lava Software (K062493). Sirona Dental 510(k) Summary October 20, 201 0 Sirona Dental CAD/CAM System… | 2006 |
What descends from it? (240)
See all 2405 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann… | 2012 | 165 |
| K111421 | Sirona Dental Cad/Cam System | 2012 | 54 |
| K103691 | Biohorizons Abutments for Zimmer | 2011 | 45 |
| K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | 2011 | 30 |
| K151455 | 3Shape Abutment Designer Software | 2016 | 10 |
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 20 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 15 of the 115 ancestors have a recall of any class.
- Of its descendants, K120822 (Institut Straumann AG, 2012) has gone furthest, with 165 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. 2010, 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 (151 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 implants systems:
* Nobel Biocare Replace (K020646)
* Nobel Biocare Branemark (K022562)
* FriadentXive (K013867)
* Biomet 3i Osseotite (K980549)
* Astra Tech Osseospeed (K091239)
* Zimmer Tapered Screw-Vent (K061410)
* Straumann SynOcta (K061176)
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/K100152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100152: Sirona 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/K100152
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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