510(k) · Cleared
ClearedStraumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN, Straumann (R) Variobase (TM) Abutment WN,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 21, 2014 as substantially equivalent to K120822 (Institut Straumann AG, 2012) and 1 other predicate after a 219-day review. Its family tree reaches back 13 generations to 1990. 35 later devices descend from it.
- Decided
- Feb 21, 2014
- Review
- 219 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K894844 (1990). 180 ancestors in all, the oldest K871863 (1987). 35 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 9 generations between
- 3 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 2 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 1 generation backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- This deviceK132219 Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase…Straumann USA, LLC · 2014
- Descendant · cites it directly · 30 of its ownK142890 Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN…Straumann USA, LLC · 2015
- Descendant · 2 generations on · 13 of its ownK151324 Straumann Variobase for CERECStraumann USA, LLC · 2015
- Descendant · 3 generations on · 7 of its ownK171532 TruBase STruabutment, Inc. · 2018
- Descendant · 4 generations on · 6 of its ownK201197 TruAbutment DS, TruBase STruabutment, Inc. · 2021
- Descendant · 2 generations on · 5 of its ownK162890 BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and…Straumann USA, LLC · 2017
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 backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 3 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 2 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 1 generation backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- This deviceK132219 Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase…Straumann USA, LLC · 2014
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC · 2015 · cites it directly30descendants
- K151324Straumann Variobase for CERECStraumann USA, LLC · 2015 · 2 generations on13descendants
- K171532TruBase STruabutment, Inc. · 2018 · 3 generations on7descendants
- K201197TruAbutment DS, TruBase STruabutment, Inc. · 2021 · 4 generations on6descendants
- K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC · 2017 · 2 generations on5descendants
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 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −3 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −2 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −1 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| 0 (this device) | K132219 | Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM)… | Straumann USA, LLC | 2014 | — |
| +1 | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann… | Straumann USA, LLC | 2015 | — |
| +2 | K151324 | Straumann Variobase for CEREC | Straumann USA, LLC | 2015 | — |
| +3 | K171532 | TruBase S | Truabutment, Inc. | 2018 | — |
| +4 | K201197 | TruAbutment DS, TruBase S | Truabutment, Inc. | 2021 | — |
| +2 | K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing… | Straumann USA, LLC | 2017 | — |
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 | 2 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 9 | 0 |
| 1996 | 14 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 8 | 0 |
| 2006 | 13 | 0 |
| 2007 | 13 | 0 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 7 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Summary page 1…Dental Implant Abutment Classification Name: Abutment, Implant, Dental, Endosseous Regulation Number: §872.3630 5.3 Predicate Device(s) 6 K120822, Straumann CARES Variobase Abutment NNC, RN, WN, NC, RC (Institut Straumann AG) * K1 11935, Ti-Base Abutment… | 2012 |
| * | K111935 | TI-Base Abutment, 1 Connect AbutmentSummary page 1…er: §872.3630 5.3 Predicate Device(s) 6 K120822, Straumann CARES Variobase Abutment NNC, RN, WN, NC, RC (Institut Straumann AG) * K1 11935, Ti-Base Abutment (NT-Trading GmbH & Co. KG) 5.4 Device Description The Straumanno Variobase' Abutments are pre-manufactur… | 2012 |
What descends from it? (35)
See all 353 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 24 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 20 of the 180 ancestors have a recall of any class.
- Of its descendants, K142890 (Straumann USA, LLC, 2015) has gone furthest, with 30 descendants of its own.
- 8 other devices also cite its predicate K120822.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Straumanho Variobase' Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straiumanw9 Variobasem Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132219: Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN, Straumann (R) Variobase (TM) Abutment WN,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132219
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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