510(k) · Cleared
ClearedMIS Ti-base abutment
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 Jul 28, 2021 as substantially equivalent to K191152 (Dentsply Sirona, 2020) after a 96-day review. Its family tree reaches back 13 generations to 1990.
- Decided
- Jul 28, 2021
- Review
- 96 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K894844 (1990). 122 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 9 generations between
- 3 generations backK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- 2 generations backK181520 Sirona Dental CAD/CAM SystemDentsply Sirona · 2018
- 1 generation backK191152 MIS Ti-base AbutmentDentsply Sirona · 2020
- This deviceK211225 MIS Ti-base abutmentDentsply Sirona · 2021
Show all 13 generations
- Root · 13 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 12 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 11 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 10 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 9 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 8 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 7 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 6 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 5 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 4 generations backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- 3 generations backK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- 2 generations backK181520 Sirona Dental CAD/CAM SystemDentsply Sirona · 2018
- 1 generation backK191152 MIS Ti-base AbutmentDentsply Sirona · 2020
- This deviceK211225 MIS Ti-base abutmentDentsply Sirona · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −12 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −11 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −10 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −9 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −8 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −7 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −6 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −5 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −4 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| −3 | K111421 | Sirona Dental Cad/Cam System | Sirona Dental Systems GmbH | 2012 | — |
| −2 | K181520 | Sirona Dental CAD/CAM System | Dentsply Sirona | 2018 | — |
| −1 | K191152 | MIS Ti-base Abutment | Dentsply Sirona | 2020 | — |
| 0 (this device) | K211225 | MIS Ti-base abutment | Dentsply Sirona | 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 |
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 |
|---|---|---|---|
| * | K191152 | MIS Ti-base AbutmentSummary page 4…II • Classification Panel: Dental Devices Panel 3. Predicate Device(s): Primary predicate device: • MIS Ti-base abutment cleared under K191152. Reference devices: • IPS e.max® CAD Abutment Solutions cleared under K191382 • VITA ENAMIC® Implant Soluti… | 2020 |
| † | K191382 | IPS e.max CAD Abutment Solutions- extra systems | 2019 |
| † | K153645 | VITA ENAMIC Implant Solutions (IS) | 2016 |
| † | K130436 | Multilink Hybrid Abutment Cement | 2013 |
| † | 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 31 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 16 of the 122 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. 2021, 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?
MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations. It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two-piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function. Narrow platform Ti-bases are…
Read the full statement (175 words)
MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations. It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two-piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function.
Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.
MIS short implants are to be used only with straight abutments. Mesostructures for use with the MIS Ti-base abutment are to be made from inCoris ZI, IPS e.max® CAD Abutment or VITA ENAMIC® (IS), designed and manufactured using Sirona CEREC SW version 4.6.1 software.
MIS Ti-base abutments are intended for use with the following MIS implants:
• C1 conical connection implant system
• V3 conical connection implant system
• SEVEN internal hex implant system
• M4 internal hex implant system
• Lance+ internal hex implant system
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211225: MIS Ti-base abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211225
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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