GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV
Device Facts
| Record ID | K113816 |
|---|---|
| Device Name | GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV |
| Applicant | GC America, Inc. |
| Product Code | NHA · Dental |
| Decision Date | Jan 30, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
Intended Use
The "GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv" is intended for use with an endossous dental implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support a tooth prosthesis, in the mandible or maxilla. The abutment screw is intended to secure the abutment to the endosseous dental implant.
Device Story
GC Aadva™ Abutments are zirconia (Y-TZP) components designed to interface with specific endosseous dental implants to support prosthetic restorations. The system includes an abutment and a titanium alloy (Ti-6Al-4V) screw for fixation. Used in dental clinics by practitioners to restore chewing function in edentulous patients. The device provides a structural connection between the implant fixture and the final tooth prosthesis. Benefit includes restoration of oral function through a biocompatible ceramic interface.
Clinical Evidence
Bench testing only. Static and fatigue testing were performed on worst-case implant-abutment assemblies in accordance with FDA guidance and ISO 14801. Results confirmed compatibility with referenced implant fixtures and demonstrated that the assemblies support adequate static and fatigue loads.
Technological Characteristics
Materials: Yttria-stabilized tetragonal zirconia (Y-TZP) per ISO 13356; Titanium alloy (Ti-6Al-4V) screw per ISO 5832-3. Features: Internal square or hexagon anti-rotational interfaces. Dimensions: Collar 2.5-6.0mm, Post 4.0-10.0mm, Angulation up to 20°. Sterilization: Not specified.
Indications for Use
Indicated for partially or fully edentulous patients requiring restoration of chewing function via attachment to a dental implant fixture placed in the maxilla or mandible.
Regulatory Classification
Identification
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
Predicate Devices
- Atlantis Straumann Bone Level Abutment (K083871)
- NobelActive Zirconia Abutment (K072129)
- GC Aadva Abutment (K072100)
- Atlantis Abutment in Zirconia for BioHorizons Implant (K073540)
- Atlantis Abutment for BioHorizons Implant (K073258)
- ATLANTIS ABUTMENT FOR ZIMMER INTERFACE (K053373)
Related Devices
- K103234 — GC AADVA BO AC ABUTMENTS · GC America, Inc. · Jun 30, 2011
- K090976 — VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS · Whip-Mix Corp. · Jun 25, 2009
- K062277 — ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE · Atlantis Components, Inc. · Dec 20, 2006
- K192053 — W Zirconia Implants · Tav Medical , Ltd. · Oct 29, 2019
- K091693 — TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK · Pou YU Biotechnology Co., Ltd. · Jul 30, 2009
Submission Summary (Full Text)
{0}------------------------------------------------
### Section 6 – 510(k) Summary
JAN 3 0 2013
## 510(k) Summary for GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv
### 510(k) Summary
# GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv
October 18, 2012 Date Prepared: .
| Submitter/Contact<br>Person | H. Carl Jenkins<br>The Wood Burditt Group<br>FDA Regulatory Counseling<br>10 E. Scranton Avenue, Suite 201<br>Lake Bluff, IL 60044<br>(ph) (847) 234-7500 x 205.<br>(fax) (847) 574-0728<br>(email) hcjenkins@woodburditt.com |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | GC America, Inc.<br>3737 W. 127th Street<br>Alsip, IL 60803<br>800.323.3386 x4042<br>708.897.4042<br>708.897.4031 (fax) |
| Manufacturer | GC CORPORATION.<br>76-1 HASUNUMA-CHO,<br>ITABASHI-KU<br>TOKYO 174-8585 JAPAN |
| Device Name | GC Aadva™ Abutments - Zirconia - Bo Ac Bh Sv |
| Common Name | Endosseous Dental Implant Abutment |
| Classification | Class II<br>Procode NHA<br>Regulation: 21 CFR 872.3630 |
{1}------------------------------------------------
#### Device Description
The "GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv" are abutments which are placed into a dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for use with the following implant fixtures:
Abutment - Implant Compatibility Table
| Types | Material | Antirotational<br>Features | Implant - Engaged Fixture<br>(Manufacturer) |
|------------------|------------------|----------------------------|---------------------------------------------------------------------------|
| IN-Bo-3.3mm #154 | Zirconia : Y-TZP | Internal Square | Ф3.3<br>Bone Level Implant NC<br>(Institut straumann AG)<br>K062129 |
| IN-Bo-4.1mm #155 | Zirconia : Y-TZP | Internal Square | Ф4.1, Ф4.8<br>Bone Level Implant RC<br>(Institut straumann AG)<br>K062129 |
| IN-Ac-3.5mm #156 | Zirconia : Y-TZP | Internal Hexagon | Ф3.5<br>NobelActive NP<br>(Nobel Biocare AB)<br>K071370 |
| IN-Ac-4.3mm #157 | Zirconia : Y-TZP | Internal Hexagon | Ф4.3, Ф5.0<br>NobelActive RP<br>(Nobel Biocare AB)<br>K071370 |
| IN-Bh-3.8mm #158 | Zirconia : Y-TZP | Internal Hexagon | Ф3.8<br>Tapered Internal Implant<br>(BioHorizons)<br>K071638 |
| IN-Bh-4.6mm #159 | Zirconia : Y-TZP | Internal Hexagon | Ф4.6<br>Tapered Internal Implant<br>(BioHorizons)<br>K071638 |
| IN-Sv-3.5mm #151 | Zirconia : Y-TZP | Internal Hexagon | Ф3.7, Ф4.1<br>Tapered Screw-Vent<br>(Zimmer Dental Inc.)<br>K013227 |
| IN Sv-4.5mm #152 | Zirconia : Y-TZP | Internal Hexagon | Ф4.7<br>Tapered Screw-Vent<br>(Zimmer Dental Inc.)<br>K013227 |
{2}------------------------------------------------
K113816
The "GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv" abutment components comply with ISO 13356:2008 – Implants for Surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). The abutments are mounted into the implant with a screw made of Titanium grade Ti-6Al-4V, which meets the requirements of ISO : 5832-3. Each of these abutments have the following design limitations:
| Types | Collar | Post | Angulation | Length | Width | Head space |
|------------------|-----------|------------|------------|------------|---------------|------------|
| IN-Bo-3.3mm #154 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| | Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.1mm | Min.1.0mm |
| IN-Bo-4.1mm #155 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| | Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.9mm | Min.1.0mm |
| I-Ac-3.5mm #156 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| | Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.1mm | Min.1.0mm |
| IN-Ac-4.3mm #157 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| | Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.9mm | Min.1.0mm |
| IN-Bh-3.8mm #158 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| | Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.1mm | Min.1.0mm |
| IN-Bh-4.6mm #159 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| | Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.9mm | Min.1.0mm |
| IN-Sv-3.5mm #151 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| | Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.1mm | Min.1.0mm |
| IN-Sv-4.5mm #152 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| | Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.9mm | Min.1.0mm |
{3}------------------------------------------------
#### Intended Use:
The "GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv" is intended for use with an endossous dental implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support a tooth prosthesis, in the mandible or maxilla. The abutment screw is intended to secure the abutment to the endosseous dental implant.
#### Indications for use:
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.
| Abutment - Implant Compatibility Table | | |
|----------------------------------------|--|--|
|----------------------------------------|--|--|
| Types | Material | Antirotational<br>Features | Implant - Engaged Fixture<br>(Manufacturer) |
|------------------|------------------|----------------------------|---------------------------------------------------------------------------|
| IN-Bo-3.3mm #154 | Zirconia : Y-TZP | Internal Square | Ф3.3<br>Bone Level Implant NC<br>(Institut straumann AG)<br>K062129 |
| IN-Bo-4.1mm #155 | Zirconia : Y-TZP | Internal Square | Ф4.1, Ф4.8<br>Bone Level Implant RC<br>(Institut straumann AG)<br>K062129 |
| IN-Ac-3.5mm #156 | Zirconia : Y-TZP | Internal Hexagon | Ф3.5<br>NobelActive NP<br>(Nobel Biocare AB)<br>K071370 |
{4}------------------------------------------------
| IN-Ac-4.3mm #157 | Zirconia : Y-TZP | Internal Hexagon | Φ4.3, Φ5.0<br>NobelActive RP<br>(Nobel Biocare AB)<br>K071370 |
|------------------|------------------|------------------|---------------------------------------------------------------------|
| IN-Bh-3.8mm #158 | Zirconia : Y-TZP | Internal Hexagon | Φ3.8<br>Tapered Internal Implant<br>(BioHorizons)<br>K071638 |
| IN-Bh-4.6mm #159 | Zirconia : Y-TZP | Internal Hexagon | Φ4.6<br>Tapered Internal Implant<br>(BioHorizons)<br>K071638 |
| IN-Sv-3.5mm #151 | Zirconia : Y-TZP | Internal Hexagon | Ф3.7, Φ4.1<br>Tapered Screw-Vent<br>(Zimmer Dental Inc.)<br>K013227 |
| IN Sv-4.5mm #152 | Zirconia : Y-TZP | Internal Hexagon | Φ4.7<br>Tapered Screw-Vent<br>(Zimmer Dental Inc.)<br>K013227 |
Prescription Use Only.
### Substantial Equivalence:
The applicant device is substantially equivalent to the predicate devices in its intended use, indications for use, and design, as described below:
| Predicate devices list | | |
|------------------------|-------------------------------------------------------------------------------------|----------|
| Product | Manufacturer | K Number |
| Atlantis<br>Abutment | Straumann Bone Level<br>Astra Tech Inc.<br>25 First Street Cambridge, Massachusetts | K083871 |
{5}------------------------------------------------
. . . . . - - -
: 上
·
:
| | 02141 USA | |
|----------------------------------------------------------|-----------------------------------------------------------------------------------|---------|
| NobelActive Zirconia Abutment | Nobel Biocare USA, LLC.<br>22715 Savi Ranch Parkway, Yorba Londa<br>CA 92887 USA | K072129 |
| GC Aadva Abutment | GC Corporation<br>76-1 Hasunuma-Cho, Itabashi-Ku<br>Tokyo, Japan | K072100 |
| Atlantis Abutment in Zirconia for<br>BioHorizons Implant | Atlantis Components Inc.<br>25 First Street Cambridge, Massachusetts<br>02141 USA | K073540 |
| Atlantis Abutment for BioHorizons<br>Implant | Atlantis Components Inc.<br>25 First Street Cambridge, Massachusetts<br>02141 USA | K073258 |
| ATLANTIS ABUTMENT FOR<br>ZIMMER INTERFACE | Astra Tech Inc.<br>25 First Street Cambridge, Massachusetts<br>02141 USA | K053373 |
:
and the control of the count
| Component | Material | Predicate devices using same materials specified<br>here |
|-----------|-----------------------------------------|----------------------------------------------------------|
| Block | Zirconia : Y-TZP | Atlantis Straumann Bone Level Abutment |
| | ISO : 13356 | (K083871) |
| | ZrO2+HfO2+Y2O3 > 99.0<br>Y2O3 : 4.5~5.4 | NobelActive Zirconia Abutment (K072129) |
| | Hf2O3<5 | GC AADVA ABUTMENT (K072100) |
{6}------------------------------------------------
| | Al2O3<0.5<br>Other oxides<0.5 | Atlantis abutment in zirconia for 3i certain interface<br>(K063734) |
|-------|--------------------------------|-----------------------------------------------------------------------|
| | | Atlantis Abutment in Zirconia for BioHorizons<br>Implant<br>(K073540) |
| | | ATLANTIS ABUTMENT FOR ZIMMER<br>INTERFACE<br>(K053373) |
| | | Atlantis Straumann Bone Level Abutment<br>(K083871) |
| Screw | Ti-6Al-4V<br>ISO : 5832-3 | NobelActive Internal Connection (K071370) |
| | Ti : Bal.<br>Al : 5.5~6.75 | GC AADVA ABUTMENT (K072100) |
| | V : 3.5~4.5<br>Fe<0.3<br>O<0.2 | Atlantis Abutment in Zirconia for BioHorizons<br>Implant (K073540) |
| | C<0.08<br>N<0.05<br>H<0.015 | Atlantis Abutment for BioHorizons Implant<br>(K073258) |
| | | ATLANTIS ABUTMENT FOR ZIMMER<br>INTERFACE<br>(K053373) |
.
1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
| Technological Characteristic | Applicant Device | Predicate Devices |
|------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Material | Zirconia : Y-TZP<br>ISO : 13356 | Zirconia : Y-TZP<br>ISO : 13356 |
| Performance Characteristics | Allows the prosthesis to be<br>retained to the abutment;<br>abutment screw is intended to | Allows the prosthesis to be<br>retained to the abutment;<br>abutment screw is intended to |
:
.
{7}------------------------------------------------
| | secure the abutment to the<br>endosseous dental implant. | secure the abutment to the<br>endosseous dental implant. |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for use with an<br>endosseous dental implant to<br>support a prosthetic device in<br>a partially or fully endentulous<br>patient to restore chewing<br>function. Intended to be<br>attached to a dental implant<br>fixture placed in the maxilla or<br>mandible. | Intended for use with an<br>endosseous dental implant to<br>support a prosthetic device in<br>a partially or fully endentulous<br>patient to restore chewing<br>function. Intended to be<br>attached to a dental implant<br>fixture placed in the maxilla or<br>mandible. |
#### Summary of Non-Clinical Performance Testing:
Static and fatigue testing was conducted on the "worst case scenario" implant-abutment combination assemblies in accordance with FDA's Guidance Document for Dental Implants and ISO 14801. Test results demonstrated that the "GC Aadva™ Abutments - Zirconia - Bo Ac Bh Sv" are compatible with the referenced implant fixtures and the implant-abutment assemblies support adequate static and fatigue test loads. Performance testing demonstrates that the device performs as intended and is as safe and effective as the cited predicates.
#### Substantial Equivalence Conclusion Statement:
Based on noted similarities and comparative traits in the indications for use, manufacturing materials, design and performance characteristics, and the fact that the applicant device and the predicate devices have demonstrated acceptable static and fatigue test loads during performance testing conducted in accordance with FDA's Guidance Document for Dental Implants and ISO 14801, the "GC Aadva™ Abutments - Zirconia - Bo Ac Bh Sv" is substantially equivalent to the following predicate devices:
| Product | Manufacturer | K Number |
|-------------------------------------------|----------------------------------------------------------------------------------|----------|
| Atlantis Straumann Bone Level<br>Abutment | Astra Tech Inc.<br>25 First Street Cambridge, Massachusetts<br>02141 USA | K083871 |
| NobelActive Zirconia Abutment | Nobel Biocare USA, LLC.<br>22715 Savi Ranch Parkway, Yorba Londa<br>CA 92887 USA | K072129 |
| GC Aadva Abutment | GC Corporation<br>76-1 Hasunuma-Cho, Itabashi-Ku<br>Tokyo, Japan | K072100 |
{8}------------------------------------------------
K113816
.
.
:
. . . . .
and the same of
| Atlantis Abutment in Zirconia for<br>BioHorizons Implant | Atlantis Components Inc.<br>25 First Street Cambridge, Massachusetts<br>02141 USA | K073540 |
|----------------------------------------------------------|-----------------------------------------------------------------------------------|---------|
| Atlantis Abutment for BioHorizons<br>Implant | Atlantis Components Inc.<br>25 First Street Cambridge, Massachusetts<br>02141 USA | K073258 |
| ATLANTIS ABUTMENT FOR<br>ZIMMER INTERFACE | Astra Tech Inc.<br>25 First Street Cambridge, Massachusetts<br>02141 USA | K053373 |
. . . . . . . .
. . . . . . .
and the control control control control controllers.
.
.
:
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing a wave or flame. The symbol is black, and the text is in a simple, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2013
GC America, Incorporated C/O Mr. Carl H. Jenkins The Wood Burditt Group 10 East Scranton Avenue, Suite 201 LAKE BLUFF IL 60044
Re: K113816
Trade/Device Name: GC AadvaTM Abutments - Zirconia - Bo Ac Bh Sv Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 17, 2013 Received: January 25, 2013
Dear Mr. Jenkins:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{10}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{11}------------------------------------------------
Section 5 - Indications for Use Statement
#### Indications for Use
510(k) Number (if known): K113816
Device Name: GC Aadva™ Abutments - Zirconia - Bo Ac Bh Sv
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.
(Cont'd on next page)
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Runner DDS, MA | 2013.01.30<br>08:08:47 -05'00' |
|----------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| (Division Sign-Off)<br>Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices<br>510(k) Number: | K113816 |
{12}------------------------------------------------
. "
### Indications for Use
510(k) Number (if known): K113816
## Device Name: GC Aadva™ Abutments - Zirconia - Bo Ac Bh Sv
(Cont'd from previous page)
Abutment - Implant Compatibility Table
| Types | Material | Antirotational<br>Features | Implant - Engaged Fixture<br>(Manufacturer) |
|------------------|------------------|----------------------------|---------------------------------------------------------------------------|
| IN-Bo-3.3mm #154 | Zirconia : Y-TZP | Internal Square | Φ3.3<br>Bone Level Implant NC<br>(Institut straumann AG)<br>K062129 |
| IN-Bo-4.1mm #155 | Zirconia : Y-TZP | Internal Square | Φ4.1, Φ4.8<br>Bone Level Implant RC<br>(Institut straumann AG)<br>K062129 |
| IN-Ac-3.5mm #156 | Zirconia : Y-TZP | Internal Hexagon | Φ3.5<br>NobelActive NP<br>(Nobel Biocare AB)<br>K071370 |
| IN-Ac-4.3mm #157 | Zirconia : Y-TZP | Internal Hexagon | Φ4.3, Φ5.0<br>NobelActive RP<br>(Nobel Biocare AB)<br>K071370 |
| IN-Bh-3.8mm #158 | Zirconia : Y-TZP | Internal Hexagon | Φ3.8<br>Tapered Internal Implant<br>(BioHorizons)<br>K071638 |
| IN-Bh-4.6mm #159 | Zirconia : Y-TZP | Internal Hexagon | Φ4.6<br>Tapered Internal Implant<br>(BioHorizons)<br>K071638 |
| IN-Sv-3.5mm #151 | Zirconia : Y-TZP | Internal Hexagon | Φ3.7, Φ4.1<br>Tapered Screw-Vent<br>(Zimmer Dental Inc.)<br>K013227 |
| IN Sv-4.5mm #152 | Zirconia : Y-TZP | Internal Hexagon | Φ4.7<br>Tapered Screw-Vent<br>(Zimmer Dental Inc.)<br>K013227 |
