510(k) · Cleared
ClearedTelio CAD Abutment Solutions- extra systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 16, 2020 as substantially equivalent to K151564 (Ivoclar Vivadent, AG, 2015) after a 363-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Nov 16, 2020
- Review
- 363 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K894844 (1990). 179 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 backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 2 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 1 generation backK151564 Telio CAD Abutment SolutionsIvoclar Vivadent, AG · 2015
- This deviceK193193 Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG · 2020
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 backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 4 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 3 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 2 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 1 generation backK151564 Telio CAD Abutment SolutionsIvoclar Vivadent, AG · 2015
- This deviceK193193 Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG · 2020
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 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −4 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −3 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −1 | K151564 | Telio CAD Abutment Solutions | Ivoclar Vivadent, AG | 2015 | — |
| 0 (this device) | K193193 | Telio CAD Abutment Solutions- extra systems | Ivoclar Vivadent, AG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 8 | 0 |
| 1996 | 13 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 8 | 0 |
| 2006 | 13 | 0 |
| 2007 | 12 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K151564 | Telio CAD Abutment SolutionsSummary page 7…(21 CFR 872.3630) Primary Product Code: NHA Secondary Product Code: PNP Primary Predicate Device: Telio ® CAD Abutment Solutions (K151564) by Ivoclar Vivadent, AG Reference Devices: Sirona Dental CAD/CAM System (K100152)… | 2015 |
| † | K100152 | Sirona Cad/Cam System | 2010 |
| † | K111421 | Sirona Dental Cad/Cam System | 2012 |
| † | K181520 | Sirona Dental CAD/CAM System | 2018 |
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 30 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 19 of the 179 ancestors have a recall of any class.
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?
Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months). The system comprises three parts: - Telio CAD Abutment Solutions - Ti base and (Dentsply Sirona K181520, Camlog K083496, Conelog K143337, iSy K133991) - CAD/CAM software: Sirona Dental CAD/CAM System (K100152, K111521, K181520) Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental…
Read the full statement (196 words)
Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months).
The system comprises three parts:
- Telio CAD Abutment Solutions
- Ti base and (Dentsply Sirona K181520, Camlog K083496, Conelog K143337, iSy K133991)
- CAD/CAM software: Sirona Dental CAD/CAM System (K100152, K111521, K181520)
Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants. The compatible implant systems, CAD/CAM systems and Ti bases are shown below:
-Implant systems:
The Telio CAD PMMA structure and TiBase hybrid abutment is compatible with the following implant systems:
– AstraTech Osseospeed (Dentsply Sirona K130999, K091239)
– Frialit/Xive (Dentsply Sirona K013867))
– internal connection (BioHorizons K143022, K071638, K093321, K042429)
– Replace (Nobel Biocare K020646)
– Nobel Active (Nobel Biocare K071370)
– Bränemark® (Nobel Biocare K022562)
– Tissue Level (Straumann K061176)
– Tapered Screw-Vent (Zimmer K061410)
– Camlog Screw-Line (Camlog K083496)
– Conelog Screw-Line (Camlog K113779)
– iSy (Camlog K133991)
– Osstem TS (Osstem (USA: Hiossen) K121585)
For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single laterial incisors in the maxilla and lateral and central incisors in the mandible.
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/K193193 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193193: Telio CAD Abutment Solutions- extra systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193193
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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