510(k) · Cleared
ClearedGC Aadva BO AC Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GC America, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 30, 2011 as substantially equivalent to K083871 (Astra Tech, Inc., 2009) and 4 other predicates after a 240-day review. Its family tree reaches back 10 generations to 1990. 1 later device descends from it.
- Decided
- Jun 30, 2011
- Review
- 240 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K894595 (1990). 114 ancestors in all, the oldest K871863 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 2 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 1 generation backK083871 Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann…Astra Tech, Inc. · 2009
- This deviceK103234 GC Aadva BO AC AbutmentsGC America, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK141970 Digitek Titanium AbutmentDigitek Dental Solutions Limited · 2015
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 7 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 6 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 4 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 3 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 2 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 1 generation backK083871 Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann…Astra Tech, Inc. · 2009
- This deviceK103234 GC Aadva BO AC AbutmentsGC America, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −7 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −6 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −4 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −3 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −2 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −1 | K083871 | Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level… | Astra Tech, Inc. | 2009 | — |
| 0 (this device) | K103234 | GC Aadva BO AC Abutments | GC America, Inc. | 2011 | — |
| +1 | K141970 | Digitek Titanium Abutment | Digitek Dental Solutions Limited | 2015 | — |
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 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 6 | 0 |
| 1996 | 11 | 0 |
| 1997 | 6 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 2 | 0 |
| 2001 | 9 | 0 |
| 2002 | 9 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (5)
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 |
|---|---|---|---|
| * | K083871 | Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Summary page 4…Manufacturer K Number Atlantis Straumann Bone Level Astra Tech Inc. K083871 Abutment 25 First Street Cambridge, Massachusetts… | 2009 |
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 4…02141 USA NobelActive Internal Connection Nobel Biocare USA, LLC. K071 370 22715 Savi Ranch Parkway, Yorba Londa… | 2007 |
| * | K072100 | GC Aadva AbutmentSummary page 4…CA 92887 USA GC Aadva Abutment GC Corporation K072 100 76-1 Hasunuma-Cho, Itabashi-Ku… | 2008 |
| * | K073258 | Atlantis Abutment for Biohorizon Implants, Atlantis Gemini Abutment for Biohorizon…Summary page 4…Tokyo, Japan Atlantis Abutment for BioHorizons Atlantis Components Inc. K073258 Implant 25 First Street Cambridge, Massachusetts _______ ___… | 2008 |
| * | K053373 | Atlantis Abutment for Zimmer InterfaceSummary page 4…_ _ _ _ _ ATLANTIS ABUTMENT FOR ZIMMER Atlantis Components, [NC. K053373 INTERFACE 8944 Tamaroa Terrace Skokie, IL 60076… | 2006 |
| † | K072129 | Nobelactive Zirconia Abutment | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141970 | Digitek Titanium Abutment | 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 21 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 14 of the 114 ancestors have a recall of any class.
- Of its descendants, K141970 (Digitek Dental Solutions Limited, 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K083871.
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?
"CAADVA TI ABUTMENTS - B0 AC SV Bff" are dental implant abutments for use with partially or fully edentulous patients to restore chewing function by attachment to a dental implant fixture placed in the maxilla or mandible. Each abument is accompanied by a screw in order to engage corresponding dental implant fixture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103234: GC Aadva BO AC Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103234
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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