510(k) · Cleared
Recalled · Class II · 2026Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
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 May 15, 2023 as substantially equivalent to K120822 (Institut Straumann AG, 2012) and 5 other predicates after a 237-day review. Its family tree reaches back 17 generations to 1996. It has been recalled once.
- Decided
- May 15, 2023
- Review
- 237 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 17 generations to K960026 (1996). 262 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 13 generations between
- 3 generations backK150182 Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 2 generations backK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
- 1 generation backK200586 Straumann TLX Implant SystemInstitut Straumann AG · 2020
- This deviceK222836 Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG · 2023
Show all 17 generations
- Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 16 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 15 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 14 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 10 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 9 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 8 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 7 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 6 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 5 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 4 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 3 generations backK150182 Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 2 generations backK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
- 1 generation backK200586 Straumann TLX Implant SystemInstitut Straumann AG · 2020
- This deviceK222836 Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −16 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −14 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −10 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −9 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −8 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −7 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −6 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −5 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −4 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −3 | K150182 | Neodent Implant System- CM Drive Implants | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −2 | K173961 | Straumann BLX Implant System | Institut Straumann AG | 2018 | — |
| −1 | K200586 | Straumann TLX Implant System | Institut Straumann AG | 2020 | — |
| 0 (this device) | K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | Institut Straumann AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 12 | 0 |
| 1994 | 12 | 0 |
| 1995 | 11 | 0 |
| 1996 | 15 | 0 |
| 1997 | 5 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 10 | 0 |
| 2001 | 16 | 0 |
| 2002 | 19 | 0 |
| 2003 | 13 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 0 |
| 2006 | 17 | 0 |
| 2007 | 19 | 0 |
| 2008 | 14 | 0 |
| 2009 | 9 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (6)
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 6…mann® Variobase® Abutments and Straumann® n!ce® Zirconia discs 510(k) Summary Predicate Device(s) Primary Predicate: • K120822 – Straumann Cares Variobase Abutments NNC, Straumann Cares Variobase Abutments RN, Straumann Cares Variobase Abutments W… | 2012 |
| * | K170356 | Straumann Variobase AbutmentsSummary page 6…0822 – Straumann Cares Variobase Abutments NNC, Straumann Cares Variobase Abutments RN, Straumann Cares Variobase Abutments WN, ST Reference Devices: • K170356 - Straumann Variobase Abutments • K190082 - Straumann BLX Variobase Abutment • K200586 - Straumann TLX Implant Syst… | 2017 |
| * | K190082 | Straumann BLX Variobase AbutmentSummary page 6…traumann Cares Variobase Abutments RN, Straumann Cares Variobase Abutments WN, ST Reference Devices: • K170356 - Straumann Variobase Abutments • K190082 - Straumann BLX Variobase Abutment • K200586 - Straumann TLX Implant System • K072569 – Metoxit Cam-Blanks •… | 2019 |
| * | K200586 | Straumann TLX Implant SystemSummary page 6…umann Cares Variobase Abutments WN, ST Reference Devices: • K170356 - Straumann Variobase Abutments • K190082 - Straumann BLX Variobase Abutment • K200586 - Straumann TLX Implant System • K072569 – Metoxit Cam-Blanks • K170050 – Z-CAD smile Device Description The purpo… | 2020 |
| * | K072569 | Metoxit Cam-BlanksSummary page 6…e Devices: • K170356 - Straumann Variobase Abutments • K190082 - Straumann BLX Variobase Abutment • K200586 - Straumann TLX Implant System • K072569 – Metoxit Cam-Blanks • K170050 – Z-CAD smile Device Description The purpose of this bundled premarket notification is to… | 2007 |
| * | K170050 | Z-CAD smileSummary page 6…nn Variobase Abutments • K190082 - Straumann BLX Variobase Abutment • K200586 - Straumann TLX Implant System • K072569 – Metoxit Cam-Blanks • K170050 – Z-CAD smile Device Description The purpose of this bundled premarket notification is to obtain regulatory clearance for the St… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 27, 2026 | Class II | Z-1995-2026 | Under Investigation by firm | Includes an incorrect screw seat interface. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 29 of the 262 ancestors have a recall of any class.
- 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. 2023, 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® Variobase® abutments are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® abutments are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and form the soft tissue during the healing phase.…
Read the full statement (159 words)
The Straumann® Variobase® abutments are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® abutments are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations.
A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion.
Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacturing by a validated milling center.
Once finalized into a suitable design:
n!ce® Zirconia LT and n!ce® Zirconia HT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to full arch.
n!ce® Zirconia XT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to 3 units.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222836 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222836: Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222836
Report an extraction error
Are you the manufacturer?
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