GC AADVA IMPLANT SYSTEM by GC AMERICA, INC.

The GC Aadva Implant System is a titanium alloy screw-type endosseous dental implant and endosseous dental implant abutment, which is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function. The GC Aadva Implant System is intended for immediate loading only when good primary stability is achieved and with appropriate occlusal loading.

Device Description

The GC Aadva Implant System is an endosseous dental implant made of Ti-6Al-4V ELI alloy and consists of several components. Geometrically, the implant is screw-type. An abutment is connected to the implant through a tapered-joint. Implants are treated with sandblast and acid etching using scanning electron microscopy (SEM). The device functions by being surgically implanted in the bone of the upper or lower jaw arches in order to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function. With regard to the scientific concepts that form the basis for the device, root-form endosseous dental implant devices are characterized by four geometrically distinct types: basket, screw, solid cylinder, and hollow cylinder. The GC Aadva Implant System is a “screw” endosseous dental implant. With regard to the physical and performance characteristics of the GC Aadva Implant System, the design shape, engaging method, implant surface treatment and dimensions (lengths and diameters) are the same as the lawfully marketed predicate GC JNE Implant System.

AI/ML Overview

The information provided is for the GC Aadva Implant System, a dental implant device, and does not involve AI or machine learning. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance Study for the GC Aadva Implant System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests Conducted	Reported Device Performance
Nonclinical Data	Material Characterization:- Solubility- Corrosion and Electrochemical properties	- Ti-6Al-4V alloy is estimated to be a corrosion-resistant material.
	Biocompatibility:- Cytotoxicity	- Ti-6Al-4V alloy is estimated to be not cytotoxic.
	Mechanical Properties:- Fatigue	- Ti-6Al-4V ELI alloy has acceptable strength according to the fatigue test results.
	Packaging System Validation:- Sterilized products and non-sterile components packaging validation	- Packaging system for sterilized products and non-sterile components is the same as the predicate JNE Implant System (K072425) in constituent materials and structure, validated according to ISO 11607-1.
	Animal Testing (Biocompatibility):- Suitability for surgical implant use (titanium alloy)	- Results indicate that Ti-6Al-4V ELI alloy is suitable for surgical implant use.
	Animal Testing (Osseointegration/Compatibility):- Compatibility to bone tissue	- Results indicate that Ti-6Al-4V ELI alloy is compatible with bone tissue.
	Compliance with Guidance Document:- Bench testing in accordance with "Guidance for Industry and FDA Staff Class II -- Special Controls Guidance Document: Root-form Endosseous Dental Implants"	- Bench testing demonstrates that this device meets the mechanical properties recommendations by FDA. (This implies that the device performed within acceptable limits defined by the guidance).
Clinical Data	No clinical data was submitted.	N/A - The submission explicitly states: "No clinical test data is being submitted with this 510(k)." Substantial equivalence was based on nonclinical data and comparison to predicate devices, showing it performs "as well or better than predicate device."

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

Test Set Sample Size: Not explicitly stated as this is not a study with a test set in the conventional sense of AI models. The "tests" refer to bench and animal studies of the material and device components. The document describes several tests conducted on the Ti-6Al-4V ELI alloy and the device system. Specific sample sizes for each nonclinical test (e.g., number of implant specimens for fatigue testing, or number of animals for biocompatibility) are not provided in this summary.
Data Provenance: The tests (solubility, corrosion, cytotoxicity, fatigue, animal testing, packaging validation) were conducted by the manufacturer (GC Corporation, Japan) and/or related testing facilities. The specific geographical origin for each test data point is not detailed beyond the manufacturer's location in Tokyo, Japan, and the sterilization facility in Gunnma, Japan. The studies are prospective insofar as they were explicitly performed to support this 510(k) submission.

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

This information is not applicable as the document describes a traditional medical device submission based on bench and animal testing, not an AI/ML device requiring human expert annotation to establish ground truth for a test set. Ground truth for material properties and biological compatibility comes from established scientific and engineering principles, international standards (ISO, ASTM), and the results of laboratory and animal experiments.

4. Adjudication Method for the Test Set

This is not applicable as there is no "test set" in the context of human interpretation or AI output that would require an adjudication method. The evaluation of test results (e.g., whether fatigue strength is "acceptable" or material is "not cytotoxic") is based on predefined pass/fail criteria from recognized standards or established scientific norms.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable as the device is a dental implant system, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as the device is a physical dental implant, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the GC Aadva Implant System is established through:

Bench Test Results: Direct measurements of physical, chemical, and mechanical properties (e.g., solubility, corrosion, fatigue strength).
Adherence to Standards: Compliance with recognized international standards such as ISO 11607-1 for packaging and unspecified ASTM/ISO standards for material properties.
Animal Testing Observations: Direct biological responses and integration in animal models (e.g., "suitability for surgical implant use," "compatibility to bone tissue").
Comparison to Predicate Devices: The concept of "substantial equivalence" is based on demonstrating that the new device has the same technological characteristics, materials, and performs "as well or better" than predicate devices that are already legally marketed and established as safe and effective.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as this is not an AI/ML device.

Summary

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5. 510(k) Summary

Submitter/ContactPerson	H. Carl JenkinsThe Wood Burditt GroupDEC - 6 2010FDA 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
Sterilization Facility	RADIA INDUSTRY CO., LTD168 OOYAGI, TAKASAKIGUNNMA 370-0072 JAPAN
Device Name	GC Aadva Implant System
Common Name	Root-form Endosseous Dental Implant and EndosseousDental Implant Abutment
Classification	Class IIProcode DZERegulation: 21 CFR 872.3640

510(k) Summary

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Identification ofPredicates and Summaryof SubstantialEquivalence	The GC Aadva Implant System is substantially equivalentwith respect to the intended use, design, risks, devicecharacteristics and performance aspects to numerous cleareddevices, including:
	510(k) / Product / Manufacturer
	- K072425 / JNE IMPLANT SYSTEM / GCAMERICA, INC.
	- K971196 / ENDOPORE ENDOSSEOUS DENTALIMPLANT SYSTEM / INNOVA CORP.
	- K002513 / ASTRA TECH IMPLANTS - DENTALSYSTEM / ASTRA TECH, INC.
	- K033984 / STRAUMANN DENTAL IMPLANTSYSTEM / INSTITUT STRAUMANN AG
	The GC Aadva Implant System is comparable to the GC JNEImplant System (K072425) in technological characteristics.More specifically, the GC Aadva Implant System and the GCJNE Implant System have the same component material,chemical composition, body type, design shape, engagingmethod, implant surface treatment and dimensions (lengthsand diameters). The GC Aadva Implant System and GC JNEImplant System also have the same indications for use.
Device Description	The GC Aadva Implant System is an endosseous dentalimplant made of Ti-6Al-4V ELI alloy and consists of severalcomponents. Geometrically, the implant is screw-type. Anabutment is connected to the implant through a tapered-joint.Implants are treated with sandblast and acid etching usingscanning electron microscopy (SEM).
	The device functions by being surgically implanted in thebone of the upper or lower jaw arches in order to providesupport for a prosthetic device, such as an artificial tooth, inorder to restore a patient's chewing function.
	With regard to the scientific concepts that form the basis forthe device, root-form endosseous dental implant devices arecharacterized by four geometrically distinct types: basket,screw, solid cylinder, and hollow cylinder. The GC Aadva
	Implant System is a “screw” endosseous dental implant. Withregard to the physical and performance characteristics of theGC Aadva Implant System, the design shape, engagingmethod, implant surface treatment and dimensions (lengthsand diameters) are the same as the lawfully marketedpredicate GC JNE Implant System.
Intended Use andIndications	The GC Aadva Implant System is a titanium alloy screw-typeendosseous dental implant and endosseous dental implantabutment, which is intended to be surgically placed in thebone of the upper or lower jaw arches to provide support for aprosthetic device, such as an artificial tooth, in order to restorea patient's chewing function.The GC Aadva Implant System is intended for immediateloading only when good primary stability is achieved and withappropriate occlusal loading.
Performance Testing	I. Nonclinical DataBench testing that studied the solubility, the corrosion andelectrochemical properties of the metals, the cytotoxicity, andthe fatigue of the GC Aadva Implant System was conducted.Testing indicated that Ti-6Al-4V alloy is estimated to be acorrosion resistant material and not cytotoxic. Furthermore,testing indicated that Ti-6Al-4V ELI alloy has acceptablestrength according to the fatigue test results.Additionally, the packaging system for sterilized products andnon-sterile components of GC Aadva Implant System is thesame as that of JNE Implant System (K072425) in constituentmaterials and the structure, which has been validatedaccording to ISO 11607-1.Animal testing that studies titanium alloy's suitability forsurgical implant use was conducted. Results indicate that Ti-6Al-4V ELI alloy is suitable for surgical implant use.Also, animal testing was conducted to determine thecompatibility of the GC Aadva Implant System to bone tissue.Results indicate that Ti-6Al-4V ELI alloy is compatible tobone tissue.Bench testing was conducted in accordance with the

procedures outlined in the Guidance for Industry and FDA
Staff Class II -- Special Controls Guidance Document: Root-
form Endosseous Dental Implants.

II. Clinical Data
No clinical test data is being submitted with this 510(k).
III. Conclusions drawn from clinical and nonclinicaldata indicating that the new device is safe andeffective for its intended use and performs aswell or better than predicate device.
Performance testing data indicates that the new device is safeand effective for its intended use and performs as well orbetter than predicate device. Specifically, testing demonstratesthat component material in the subject device is the same asthe component material in a predicate device, and conforms torelevant ISO and ASTM standards. Bench testing conductedin accordance with the procedures outlined in the Guidancefor Industry and FDA Staff Class II -- Special ControlsGuidance Document: Root-form Endosseous Dental Implantsdemonstrates that this device meets the mechanical propertiesrecommendations by FDA.

510(k) Summary

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

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

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

Re: K093749

DEC - 6 2010

Trade/Device Name: GC Aadva Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: November 24, 2010 Received: November 26, 2010

and the comments of the count . . :

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.

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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,

th fis

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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4. Indications for Use

DEC - 6 2010

510(k) Number (if known): K093749

Device Name: GC Aadva Implant System

Indications for Use:

The GC Aadva Implant System is intended for immediate loading only when good primary stability is achieved and with appropriate occlusal loading.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) times (current

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

510(k) Number: K093741 Page 4.1 of 4.1

Indications For Use

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.