510(k) · Cleared
ClearedSirona Dental CAD/CAM System with CEREC Chairside Software
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 Aug 16, 2020 as substantially equivalent to K181520 (Dentsply Sirona, 2018) after a 251-day review. Its family tree reaches back 12 generations to 1990. 2 later devices descend from it.
- Decided
- Aug 16, 2020
- Review
- 251 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894844 (1990). 121 ancestors in all, the oldest K871863 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 8 generations between
- 3 generations backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- 2 generations backK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- 1 generation backK181520 Sirona Dental CAD/CAM SystemDentsply Sirona · 2018
- This deviceK193408 Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona · 2020
- Descendant · cites it directly · 0 of its ownK250295 Dentsply Sirona Titanium Bases systemDentsply Sirona · 2025
- Descendant · cites it directly · 0 of its ownK233285 KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc. · 2024
Show all 12 generations
- Root · 12 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 11 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 10 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 9 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 8 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 7 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 6 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 5 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 4 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 3 generations backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- 2 generations backK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- 1 generation backK181520 Sirona Dental CAD/CAM SystemDentsply Sirona · 2018
- This deviceK193408 Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona · 2020
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 |
|---|---|---|---|---|---|
| −12 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −11 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −10 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −9 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −8 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −7 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −6 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −5 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −4 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −3 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| −2 | K111421 | Sirona Dental Cad/Cam System | Sirona Dental Systems GmbH | 2012 | — |
| −1 | K181520 | Sirona Dental CAD/CAM System | Dentsply Sirona | 2018 | — |
| 0 (this device) | K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software | Dentsply Sirona | 2020 | — |
| +1 | K250295 | Dentsply Sirona Titanium Bases system | Dentsply Sirona | 2025 | — |
| +1 | 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 |
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.
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 30 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 16 of the 121 ancestors have a recall of any class.
- Of its descendants, K250295 (Dentsply Sirona, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K181520.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 with CEREC Chairside Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the AT TX 3.0 S, BH 3.0 S, SSO 3.5 L, and 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. The system consists of three major…
Read the full statement (396 words)
The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the AT TX 3.0 S, BH 3.0 S, SSO 3.5 L, and 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. 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: NP, 3.5; RP, 4.3; WP, 5.0; 6.0, 6.0. Active: NP, 3.5; RP, 4.3/5.0. Branemark: NP, 3.3; RP, 3.75/4.0.
Straumann — Synocta: NN (3.5mm), 3.3; RN (4.8mm), 3.3/4.1/4.8; WN (6.5mm), 4.8. Bone Level: NC (3.3mm), 3.3; RC (4.1mm/4.8mm), 4.1/4.8.
Dentsply Sirona Implants — Osseospeed: 3.5/4.0, 3.5 S / 4.0 S; 4.5/5.0, 4.5/5.0/5.0 S. Xive: 3.4, 3.4; 3.8, 3.8; 4.5, 4.5; 5.5, 5.5. Osseospeed EV: 3.6, 3.6; 4.2, 4.2; 4.8, 4.8; 5.4, 5.4. Ankylos: C/X, A, B, C, D. Osseospeed TX: 3.0, 3.0; 3.5/4.0, 3.5/4.0; 4.5/5.0, 4.5/5.0.
Biomet 3i — Osseotite: 3.4, 3.25 / 3.75; 4.1, 4.1 / 3/4; 5.0, 5.0 / 4/5. Certain: 3.4, 3.25 / 4/3 / 3/4/3; 4.1, 4.0 / 4/5/4 / 5/4; 5.0, 5.0 / 4/5.
Zimmer — Tapered Screw-Vent: 3.5, 3.7/4.1; 4.5, 4.7; 5.7, 6.
Thommen Medical — Thommen Medical Implants: 3.5, 3.5; 4, 4; 4.5, 4.5; 5, 5; 6, 6.
Osstem / Hiossen — Osstem TS Implant System: Mini, 3.5. Hiossen Implant System: Regular, 4.0/4.5/5.0/6.0/7.0.
BioHorizons (Internal Connection) — Tapered 3.0, Tapered plus: 3.0, 3.0/3.4/3.8; Tapered internal: 3.0, 3.0; Tapered plus: 4.6; Tapered internal, Tapered internal tissue level: 3.5, 3.0/3.8; Internal dental implant: 3.5; Single stage dental implants: 3.5/4.0; Tapered Plus: 5.8; Tapered internal, Tapered internal tissue level: 4.5, 4.6; Internal dental implant: 4.0; Single stage dental implants: 4.0/5.0; Tapered internal, Tapered internal tissue level: 5.7, 5.8; Internal dental implant, Single stage dental implants: 5.0/6.0.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193408 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193408: Sirona Dental CAD/CAM System with CEREC Chairside Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193408
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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