# K113816: GC Aadva Abutment- Zirconium-BO AC BH SV

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jan 30, 2013 after 400 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K944964 (1995). 117 ancestors in all.
No later device cites it as a predicate yet.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083871: Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment, Atlantis Gemini + Straumann Bone, Astra Tech, Inc. (2009) Summary page 5.
- K072129: Nobelactive Zirconia Abutment, Nobel Biocare AB (2008) Summary page 6.
- K072100: GC Aadva Abutment, GC America, Inc. (2008) Summary page 6.
- K073540: Atlantis Abutment in Zirconia for Biohorizons Implant, Atlantis Components, Inc. (2008) Summary page 6.
- K073258: Atlantis Abutment for Biohorizon Implants, Atlantis Gemini Abutment for Biohorizon Implants, Atlantis Gemini + Abutment, Atlantis Components, Inc. (2008) Summary page 6.
- K053373: Atlantis Abutment for Zimmer Interface, Atlantis Components, Inc. (2006) Summary page 6.

## Indications for use
GC Aadva™ Abutments - Zirconia - Bo Ac Bh Sv 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 abutment is accompanied by a screw in order to engage corresponding dental implant fixture.

Source page: https://510kreport.com/device/K113816
Methodology: https://510kreport.com/methodology