510(k) · Cleared
ClearedStraumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 21, 2012 as substantially equivalent to K093113 (Institut Straumann AG, 2009) and 12 other predicates after a 277-day review. Its family tree reaches back 12 generations to 1990. 165 later devices descend from it.
- Decided
- Dec 21, 2012
- Review
- 277 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 12 generations to K894844 (1990). 169 ancestors in all, the oldest K871863 (1987). 165 later devices descend from it, 9 citing it directly.
- Root · 12 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 8 generations between
- 3 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 2 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 1 generation backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- This deviceK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · cites it directly · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · cites it directly · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 3 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 3 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
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 backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 2 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 1 generation backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- This deviceK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
Showing 5 of 165 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 165 · See all- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · cites it directly129descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · cites it directly89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 3 generations on51descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 3 generations on38descendants
View 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 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −2 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −1 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| 0 (this device) | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +1 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +1 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +3 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +3 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
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 | 11 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 10 | 0 |
| 2019 | 7 | 0 |
| 2020 | 12 | 0 |
| 2021 | 17 | 0 |
| 2022 | 14 | 0 |
| 2023 | 24 | 0 |
| 2024 | 24 | 0 |
| 2025 | 25 | 0 |
| 2026 | 11 | 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? (13)
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 |
|---|---|---|---|
| * | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentSummary page 1…tion Number: 21CFR872.3630 5.4 Predicate Devices ETKON ESi, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM K093113 ABUTMENT STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR K101465 S… | 2009 |
| * | K101465 | Straumann Cares Bridge; Straumann Cares Dolder BarSummary page 1…ON VISUAL, STRAUMANN CADCAM K093113 ABUTMENT STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR K101465 STRAUMANN DENTAL IMPLANT SYSTEM K083550 NNC CEMENTABLE ABUT… | 2010 |
| * | K083550 | Straumann Dental Implant SystemSummary page 1…RES BRIDGE; STRAUMANN CARES DOLDER BAR K101465 STRAUMANN DENTAL IMPLANT SYSTEM K083550 NNC CEMENTABLE ABUTMENT STRAIGHTI1 5 DEGREE ANGLE, TYPE A,15 K113283 DEGREE ANGLE, TYPE B… | 2009 |
| * | K113283 | NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Summary page 1…NTAL IMPLANT SYSTEM K083550 NNC CEMENTABLE ABUTMENT STRAIGHTI1 5 DEGREE ANGLE, TYPE A,15 K113283 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS STRAUMANN COMPUTER AIDED RESTORATION SERVICE… | 2011 |
| * | K052272 | Straumann Computer Aided Restoration ServiceSummary page 1…K113283 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS STRAUMANN COMPUTER AIDED RESTORATION SERVICE K052272 STRAUMANN WN CARES TITANIUM ABUTMENT K082764 P.004 NC CARES TITA… | 2006 |
| * | K082764 | Straumann WN Cares Titanium AbutmentSummary page 1…MPUTER AIDED RESTORATION SERVICE K052272 STRAUMANN WN CARES TITANIUM ABUTMENT K082764 P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS K081005 Al Response: Ki120822… | 2008 |
| * | K081005 | P.004 NC Cares Titanium and Ceramic AbutmentsSummary page 1…CARES TITANIUM ABUTMENT K082764 P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS K081005 Al Response: Ki120822 Straumann Variobase Abutments Page 227 of 269… | 2008 |
| * | K072151 | P.004 RC Cares Titanium and Ceramic AbutmentsSummary page 2…4 s m m n 5 Errorl Reference source not found. P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS K072151 LAVA FRAME, LAVA FRAME SHADE K072055 SIRONA CAD/CAM SYSTEM… | 2007 |
| * | K072055 | Lava Frame, Lava Frame ShadeSummary page 2…ARES TITANIUM AND CERAMIC ABUTMENTS K072151 LAVA FRAME, LAVA FRAME SHADE K072055 SIRONA CAD/CAM SYSTEM K1 001 52 METOXIT CAM-BLANKS… | 2008 |
| * | K100152 | Sirona Cad/Cam SystemSummary page 2…, LAVA FRAME SHADE K072055 SIRONA CAD/CAM SYSTEM K1 001 52 METOXIT CAM-BLANKS K072569 NACERA Z AND NACERA Z M… | 2010 |
| * | K072569 | Metoxit Cam-BlanksSummary page 2…AM SYSTEM K1 001 52 METOXIT CAM-BLANKS K072569 NACERA Z AND NACERA Z MEDIUM K080195 WIELAND ZENO CAO TEMPOR… | 2007 |
| * | K080195 | Nacera Z and Nacera Z MediumSummary page 2…M-BLANKS K072569 NACERA Z AND NACERA Z MEDIUM K080195 WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED K071 548 5.5 Descriptio… | 2008 |
| * | K071548 | Wieland Zeno Cao Temporary Pmma Disc, Tooth-ColoredSummary page 2…ND NACERA Z MEDIUM K080195 WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED K071 548 5.5 Description of the Device 5.5.1 Straumann® CARES® VariobaseTM portfolio The Straumann® C… | 2007 |
What descends from it? (165)
See all 1659 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150203 | Medentika CAD/CAM Abutments | 2015 | 129 |
| K150367 | Neodent Implant System | 2015 | 89 |
| K132219 | Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN… | 2014 | 35 |
| K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase… | 2015 | 30 |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC… | 2017 | 5 |
| K171649 | Straumann CARES M-Series CAD/CAM System | 2018 | 3 |
| K151564 | Telio CAD Abutment Solutions | 2015 | 1 |
| K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | 2023 | 0 |
| K142557 | Anker Dental Implant System - SB-III, ST and AT series | 2015 | 0 |
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 3 companies; a new generation was cleared every 1.3 years on median.
- 18 of the 169 ancestors have a recall of any class.
- Of its descendants, K150203 (Medentika GmbH, 2015) has gone furthest, with 129 descendants of its own.
- 2 other devices also cite its predicate K093113.
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 Straumann® CARES® Variobase™ Abutment is a two-piece dental abutment consisting of the Straumann Variobase™ Abutment and the Straumann® CARES® Variobase™ Coping which is intended to be placed onto Straumann dental implants to provide support for prosthetic reconstruction such as crowns and bridges. Straumann® CARES® Variobase™ Abutments are indicated for screw-retained single tooth or cement-retained, single tooth and bridge restorations.
The Straumann® CARES® Variobase™ Coping polycon® ae in combination with the Straumann® Variobase™ Abutment is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120822
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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