510(k) · Cleared
ClearedCamlog Vario SR Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altatec GmbH · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jan 10, 2011 as substantially equivalent to K061477 (Nobel Biocare AB, 2006) and 6 other predicates after a 68-day review. Its family tree reaches back 8 generations to 1990. 32 later devices descend from it.
- Decided
- Jan 10, 2011
- Review
- 68 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K894595 (1990). 78 ancestors in all, the oldest K871863 (1987). 32 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 5 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 2 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 1 generation backK061477 Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant SystemsNobel Biocare AB · 2006
- This deviceK103252 Camlog Vario SR AbutmentsAltatec GmbH · 2011
- Descendant · cites it directly · 16 of its ownK121334 VarioecoThommen Medical AG · 2012
- Descendant · 2 generations on · 15 of its ownK160244 VARIOuniteThommen Medical AG · 2016
- Descendant · cites it directly · 14 of its ownK113779 Conelog Implant SystemAltatec GmbH · 2012
- Descendant · 3 generations on · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 9 of its ownK193401 Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH · 2020
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K121334VarioecoThommen Medical AG · 2012 · cites it directly16descendants
- K160244VARIOuniteThommen Medical AG · 2016 · 2 generations on15descendants
- K113779Conelog Implant SystemAltatec GmbH · 2012 · cites it directly14descendants
- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · 3 generations on13descendants
- K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH · 2020 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −5 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −2 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| −1 | K061477 | Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems | Nobel Biocare AB | 2006 | — |
| 0 (this device) | K103252 | Camlog Vario SR Abutments | Altatec GmbH | 2011 | — |
| +1 | K121334 | Varioeco | Thommen Medical AG | 2012 | — |
| +2 | K160244 | VARIOunite | Thommen Medical AG | 2016 | — |
| +1 | K113779 | Conelog Implant System | Altatec GmbH | 2012 | — |
| +3 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| +2 | K193401 | Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants | Altatec GmbH | 2020 | — |
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 | 10 | 0 |
| 1994 | 9 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (7)
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 |
|---|---|---|---|
| * | K061477 | Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant SystemsSummary page 2…e substantially equivalent to pre-amendment devices: * Nobel Biocare USA LLC, Multi-Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, cleared under K061477; * Nobel Biocare USA LLC, Procera Titaniumn Abutment for Astra Tech and Camlog Implant Systems, cleared under K06 1478; *No… | 2006 |
| * | K061478 | Procera Titanium Abutment for Astratech and Camlog Implant SystemsSummary page 2…g and Ankylos Implant Systems, cleared under K061477; * Nobel Biocare USA LLC, Procera Titaniumn Abutment for Astra Tech and Camlog Implant Systems, cleared under K06 1478; *Nobel Biocare USA LLC, Procera® Implant Bridge, cleared under K043042; *Nobel Biocare USA LLC, Procera® Abutment BrAnemark,… | 2006 |
| * | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Summary page 2…SA LLC, Procera Titaniumn Abutment for Astra Tech and Camlog Implant Systems, cleared under K06 1478; *Nobel Biocare USA LLC, Procera® Implant Bridge, cleared under K043042; *Nobel Biocare USA LLC, Procera® Abutment BrAnemark, cleared under K042658; *Thommen Medical AG, SPI® VARlOmulti Abutment, c… | 2004 |
| * | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Summary page 2…s, cleared under K06 1478; *Nobel Biocare USA LLC, Procera® Implant Bridge, cleared under K043042; *Nobel Biocare USA LLC, Procera® Abutment BrAnemark, cleared under K042658; *Thommen Medical AG, SPI® VARlOmulti Abutment, cleared under K072856; *Thommen Medical AG, SPI® VARlOmulti Angled Abutment,… | 2004 |
| * | K072856 | Spi Variomulti AbutmentSummary page 2…idge, cleared under K043042; *Nobel Biocare USA LLC, Procera® Abutment BrAnemark, cleared under K042658; *Thommen Medical AG, SPI® VARlOmulti Abutment, cleared under K072856; *Thommen Medical AG, SPI® VARlOmulti Angled Abutment, cleared under K090 153; and *Thommen Medical AG, SPI® VARI0multi Angle… | 2008 |
| * | K090153 | Spi Variomulti Angled AbutmentSummary page 2…ark, cleared under K042658; *Thommen Medical AG, SPI® VARlOmulti Abutment, cleared under K072856; *Thommen Medical AG, SPI® VARlOmulti Angled Abutment, cleared under K090 153; and *Thommen Medical AG, SPI® VARI0multi Angled Abutment, cleared under K 10 1798. TESTING Mechanical testing was performed… | 2009 |
| * | K101798 | Spi Variomulti Angled AbutmentSummary page 2…under K072856; *Thommen Medical AG, SPI® VARlOmulti Angled Abutment, cleared under K090 153; and *Thommen Medical AG, SPI® VARI0multi Angled Abutment, cleared under K 10 1798. TESTING Mechanical testing was performed according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous de… | 2010 |
What descends from it? (32)
See all 322 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 21 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 9 of the 78 ancestors have a recall of any class.
- Of its descendants, K121334 (Thommen Medical AG, 2012) has gone furthest, with 16 descendants of its own.
- 5 other devices also cite its predicate K061477.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
CAMLOG® Vario SR components for crown and bridge restorations:
*Occlusal screw-retained crown, bridge and bar constructions on CAMLOG® implants (with J and K article numbers) in the anterior and posterior region of the maxilla and mandible
CAMLOG® Vario SR components for bar restorations:
*Anchorage of implant-supported full dentures for the edentulous maxilla and mandible in combination with 2, 4 or more CAMLOG® implants (with J and K article numbers)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103252: Camlog Vario SR Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103252
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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