"GC AADVA TI ABUTMENTS – BO AC SV BH" 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.

Device Description

The "GC Aadva Ti Abutments – Bo Ac Sv Bh" 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: IN-Bo-3.3mm #354, IN-Bo-4.1mm #355, IN-Ac-3.5mm #356, IN-Ac-4.3mm #357, IN-Bh-3.8mm #358, IN-Bh-4.6mm #359, IN-Bh-5.8mm #360, IN-Sv-3.5mm #351, IN-Sv-4.5mm #352, IN-Sv-5.7mm #353. The "GC Aadva Ti Abutments – Bo Ac Sv Bh" components are made of Titanium grade Ti-6Al-4V and meets the requirements of ISO : 5832-3. The abutments are mounted into the implant with a screw also made of Titanium grade Ti-6A1-4V, which meets the requirements of ISO : 5832-3.

AI/ML Overview

The provided text describes the "GC AADVA TI ABUTMENTS – BO AC SV BH" and its substantial equivalence to predicate devices, focusing on materials, intended use, and performance characteristics.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from ISO 14801 and FDA Guidance)	Reported Device Performance (Worst Case Scenario)
Static Test Loads (Adequate)	Test results demonstrated that the "GC Aadva Ti Abutments – Bo Ac Sv Bh" and implant-abutment assemblies support adequate static test loads.
Fatigue Test Loads (Adequate)	Test results demonstrated that the "GC Aadva Ti Abutments – Bo Ac Sv Bh" and implant-abutment assemblies support adequate fatigue test loads.
Compatibility with Referenced Implant Fixtures	Test results demonstrated that the "GC Aadva Ti Abutments – Bo Ac Sv Bh" are compatible with the referenced implant fixtures.
Performs as Intended	Performance testing demonstrates that the device performs as intended.
Safe and Effective (compared to predicates)	Performance testing demonstrates that the device is as safe and effective as the cited predicates.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the exact number of implant-abutment assemblies tested. It refers to testing on the "worst case scenario" implant-abutment combination assemblies.
Data Provenance: The study was conducted by GC America, Inc. and GC Corporation (manufacturer). The country of origin for the manufacturing is Japan (GC Corporation) and the submitter is in the US. The study is prospective in the sense that physical tests were performed on the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The "ground truth" for this type of device (dental abutments) is typically established through adherence to engineering standards and mechanical testing, not expert consensus or clinical observation in the same way a diagnostic device would. The "truth" is whether the device can withstand the specified loads without failure.

4. Adjudication Method for the Test Set:

This information is not applicable as the evaluation is based on mechanical performance against predefined standards (ISO 14801 and FDA Guidance), not expert judgment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a dental implant abutment, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related metrics like human reader improvement are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical medical device (dental abutment), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on established engineering standards and regulatory guidance for mechanical performance. Specifically, the device's performance was evaluated against the requirements of ISO 14801 (Dentistry - Implants - Dynamic loading test for endosseous dental implants) and FDA's Guidance Document for Dental Implants. The "truth" is defined by meeting the specified static and fatigue load requirements.

8. The Sample Size for the Training Set:

This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering principles and iterative testing, not through training data.

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the reasons stated above.

Summary

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K103234 JUN 3 0 2011

510(k) Summary

GC AADVA TI ABUTMENTS – BO AC SV BH

1994 : 1999 : 1999 : 1999 : 1999 : 1999 : 1999 : 1999 : 1999 : 1999 :

Date Prepared: June 10, 2011

Submitter/ContactPerson	H. Carl JenkinsThe Wood Burditt GroupFDA Regulatory Counseling10 E. Scranton Avenue, Suite 201Lake Bluff, IL 60044(ph) (847) 234-7500 x 205(fax) (847) 574-0728(email) hcjenkins@woodburditt.com
Applicant	GC America, Inc.3737 W. 127th StreetAlsip, IL 60803800.323.3386 x4042708.897.4042708.897.4031 (fax)
Manufacturer	GC CORPORATION.76-1 HASUNUMA-CHO,ITABASHI-KUTOKYO 174-8585 JAPAN
Device Name	GC AADVA TI ABUTMENTS - BO AC SV BH
Common Name	Endosseous Dental Implant Abutment
Classification	Class IIProcode NHARegulation: 21 CFR 872.3630

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Device Description

. . .

Types	Material	AntirotationalFeatures	Engaged Fixture(Manufacturer)
IN-Bo-3.3mm #354	Ti-6Al-4V	Internal Square	$\Phi$ 3.3Bone Level Implant NC(Institut straumann AG)
IN-Bo-4.1mm #355	Ti-6Al-4V	Internal Square	$\Phi$ 4.1, $\Phi$ 4.8Bone Level Implant RC(Institut straumann AG)
IN-Ac-3.5mm #356	Ti-6Al-4V	Internal Hexagon	$\Phi$ 3.5NobelActive NP(Nobel Biocare AB)
IN-Ac-4.3mm #357	Ti-6Al-4V	Internal Hexagon	$\Phi$ 4.3, $\Phi$ 5.0NobelActive RP(Nobel Biocare AB)
IN-Bh-3.8mm #358	Ti-6Al-4V	Internal Hexagon	$\Phi$ 3.8mmTapered Internal Implant(BioHorizons)
IN-Bh-4.6mm #359	Ti-6Al-4V	Internal Hexagon	$\Phi$ 4.6mmTapered Internal Implant(BioHorizons)
IN-Bh-5.8mm #360	Ti-6Al-4V	Internal Hexagon	$\Phi$ 5.8mmTapered Internal Implant(BioHorizons)
IN-Sv-3.5mm #351	Ti-6Al-4V	Internal Hexagon	$\Phi$ 3.7, $\Phi$ 4.1Tapered Screw-Vent(Zimmmer)
IN-Sv-4.5mm #352	Ti-6Al-4V	Internal Hexagon	$\Phi$ 4.7Tapered Screw-Vent(Zimmmer)
IN-Sv-5.7mm #353	Ti-6Al-4V	Internal Hexagon	$\Phi$ 6.0Tapered Screw-Vent(Zimmer)

The "GC Aadva Ti Abutments – Bo Ac Sv Bh" components are made of Titanium grade Ti-6Al-4V and meets the requirements of ISO : 5832-3. The abutments are mounted into the implant

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Collar	Angulation	Length	Width	Head space
Max.6.0mmMin.2.5mm	Max.20°Min.0°	Max.12.0mmMin.2.5mm -3.5mm(dependingon abutmentselected)	Max. $\Phi$ 11.6mmMin. $\Phi$ 4.1mm -$\Phi$ 6.1mm(depending onabutmentselected)	Max.11.8mmMin.1.0mm

with a screw also made of Titanium grade Ti-6A1-4V, which meets the requirements of ISO : 5832-3. Each of these abutments have the following design limitations:

Intended Use:

The "GC Aadva Ti Abutments – Bo Ac Sv Bh" 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 TI ABUTMENTS – BO AC SV BH" 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	Material	AntirotationalFeatures	Implant -- Engaged Fixture(Manufacturer)
IN-Bo-3.3mm #354	Ti-6A1-4V	Internal Square	Ф3.3Bone Level Implant NC(Institut straumann AG)
IN-Bo-4.1mm #355	Ti-6Al-4V	Internal Square	Ф4.1, Ф4.8Bone Level Implant RC(Institut straumann AG)
IN-Ac-3.5mm #356	Ti-6Al-4V	Internal Hexagon	Ф3.5NobelActive NP(Nobel Biocare AB)
IN-Ac-4.3mm #357	Ti-6Al-4V	Internal Hexagon	Ф4.3, Ф5.0NobelActive RP(Nobel Biocare AB)

Abutment - Implant Compatibility Tahle

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IN-Bh-3.8mm #358	Ti-6Al-4V	Internal Hexagon	$\Phi$ 3.8mmTapered Internal Implant(BioHorizons)
IN-Bh-4.6mm #359	Ti-6Al-4V	Internal Hexagon	$\Phi$ 4.6mmTapered Internal Implant(BioHorizons)
IN-Bh-5.8mm #360	Ti-6Al-4V	Internal Hexagon	$\Phi$ 5.8mmTapered Internal Implant(BioHorizons)
IN-Sv-3.5mm #351	Ti-6Al-4V	Internal Hexagon	$\Phi$ 3.7, $\Phi$ 4.1Tapered Screw-Vent(Zimmmer)
IN-Sv-4.5mm #352	Ti-6Al-4V	Internal Hexagon	$\Phi$ 4.7Tapered Screw-Vent(Zimmmer)
IN-Sv-5.7mm #353	Ti-6Al-4V	Internal Hexagon	$\Phi$ 6.0Tapered Screw-Vent(Zimmmer)

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:

Product	Manufacturer	K Number
Atlantis Straumann Bone LevelAbutment	Astra Tech Inc.25 First Street Cambridge, Massachusetts02141 USA	K083871
NobelActive Internal Connection	Nobel Biocare USA, LLC.22715 Savi Ranch Parkway, Yorba LondaCA 92887 USA	K071370
GC Aadva Abutment	GC Corporation76-1 Hasunuma-Cho, Itabashi-KuTokyo, Japan	K072100
Atlantis Abutment for BioHorizonsImplant	Atlantis Components Inc.25 First Street Cambridge, Massachusetts02141 USA	K073258
ATLANTIS ABUTMENT FOR ZIMMERINTERFACE	Atlantis Components, INC.8944 Tamaroa Terrace Skokie, IL 60076	K053373

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Component	Applicant Device Materials	Predicate Devices that Use Same Materials
Block	Ti-6Al-4VISO : 5832-3Ti : Bal.Al : 5.5~~6.75V : 3.5~~4.5Fe<0.3O<0.2C<0.08N<0.05H<0.015	Atlantis Straumann Bone Level Abutment(K083871)NobelActive Internal Connection (K071370)GC AADVA ABUTMENT (K072100)Atlantis Abutment for BioHorizons Implant(K073258)ATLANTIS ABUTMENT FOR ZIMMER INTERFACE(K053373)
	Screw	Ti-6Al-4VISO : 5832-3Ti : Bal.Al : 5.5~~6.75V : 3.5~~4.5Fe<0.3O<0.2C<0.08N<0.05H<0.015	Atlantis Straumann Bone Level Abutment(K083871)NobelActive Internal Connection (K071370)NobelActive Zirconia Abutment (K072129)GC AADVA ABUTMENT (K072100)Atlantis Abutment for BioHorizons Implant(K073258)ATLANTIS ABUTMENT FOR ZIMMER INTERFACE(K053373)

Technological Characteristic	Applicant Device	Predicate Devices
Material	Ti-6Al-4VISO : 5832-3	Ti-6Al-4VISO : 5832-3
Performance Characteristics	Allows the prosthesis to beretained to the abutment;abutment screw is intended tosecure the abutment to theendosseous dental implant.	Allows the prosthesis to beretained to the abutment;abutment screw is intended tosecure the abutment to theendosseous dental implant.
Intended Use	Intended for use with anendosseous dental implant tosupport a prosthetic device ina partially or fully endentulouspatient to restore chewing	Intended for use with anendosseous dental implant tosupport a prosthetic device ina partially or fully endentulouspatient to restore chewing

Materials used in blocks and screws

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	function. Intended to beattached to a dental implantfixture placed in the maxilla ormandible.	function. Intended to beattached to a dental implantfixture placed in the maxilla ormandible.
--	-----------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------

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 Ti Abutments – Bo Ac Sv Bh" 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 Ti Abutments – Bo Ac Sv Bh" is substantially equivalent to the following predicate devices:

Product	Manufacturer	K Number
Atlantis Straumann Bone LevelAbutment	Astra Tech Inc.25 First Street Cambridge, Massachusetts02141 USA	K083871
NobelActive Internal Connection	Nobel Biocare USA, LLC.22715 Savi Ranch Parkway, Yorba LondaCA 92887 USA	K071370
GC Aadva Abutment	GC Corporation76-1 Hasunuma-Cho, Itabashi-KuTokyo, Japan	K072100
Atlantis Abutment for BioHorizonsImplant	Atlantis Components Inc.25 First Street Cambridge, Massachusetts02141 USA	K073258
ATLANTIS ABUTMENT FOR ZIMMERINTERFACE	Atlantis Components, INC.8944 Tamaroa Terrace Skokie, IL 60076	K053373

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

GC America, Incorporated C/O Mr. H. Carl Jenkins Wood Burditt Group 10 East Scranton Avenue. Suite 201 Lake Bluff. Illinois 60044

JUN 3 0 2011

Re: K103234

Trade/Device Name: GC AADVA TI ABUTMENTS - BO AC SV BH Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 10, 2011 Received: June 13, 2011

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 ffor 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.

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Page 2 – Mr. Jenkins

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,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 5 - Indications for Use Statement

Indications for Use

510(k) Number (if known):

Device Name: GC AADVA TI ABUTMENTS - BO AC SV BH

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)
--------------------------------------------------------	--

Susa Luise

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 5.1.of 5.2

510(k) Number: 1403234

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Abutment – Implant Compatibility Table

Abutment	Material	Antirotational Features	Implant -- Engaged Fixture (Manufacturer)
IN-Bo-3.3mm #354	Ti-6Al-4V	Internal Square	$\phi$ 3.3Bone Level Implant NC(Institut straumann AG)
IN-Bo-4.1mm #355	Ti-6Al-4V	Internal Square	$\phi$ 4.1, $\phi$ 4.8Bone Level Implant RC(Institut straumann AG)
IN-Ac-3.5mm #356	Ti-6Al-4V	Internal Hexagon	$\phi$ 3.5NobelActive NP(Nobel Biocare AB)
IN-Ac-4.3mm #357	Ti-6Al-4V	Internal Hexagon	$\phi$ 4.3, $\phi$ 5.0NobelActive RP(Nobel Biocare AB)
IN-Bh-3.8mm #358	Ti-6Al-4V	Internal Hexagon	$\phi$ 3.8mmTapered Internal Implant(BioHorizons)
IN-Bh-4.6mm #359	Ti-6Al-4V	Internal Hexagon	$\phi$ 4.6mmTapered Internal Implant(BioHorizons)
IN-Bh-5.8mm #360	Ti-6Al-4V	Internal Hexagon	$\phi$ 5.8mmTapered Internal Implant(BioHorizons)
IN-Sv-3.5mm #351	Ti-6Al-4V	Internal Hexagon	$\phi$ 3.7, $\phi$ 4.1Tapered Screw-Vent(Zimmer)
IN-Sv-4.5mm #352	Ti-6Al-4V	Internal Hexagon	$\phi$ 4.7Tapered Screw-Vent(Zimmer)
IN-Sv-5.7mm #353	Ti-6Al-4V	Internal Hexagon	$\phi$ 6.0Tapered Screw-Vent(Zimmer)

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)

Page 5.2 of 5.2

... ... ... ... ..............................................................................................................................................................

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)