(364 days)
Not Found
No
The 510(k) summary describes a traditional dental implant system made of titanium alloy. There is no mention of AI, ML, algorithms, software for analysis, or any other technology that would suggest the use of AI/ML. The testing described is focused on material properties and mechanical performance.
Yes
The device is described as an implant system intended to restore a patient's chewing function, which is a therapeutic purpose.
No
The device is a dental implant system used to provide support for prosthetic devices to restore chewing function. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a physical implant made of titanium alloy and consists of several components, requiring surgical placement. It is not software.
Based on the provided text, the GC Aadva Implant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is surgically placed in the bone to support a prosthetic device and restore chewing function. This is a direct therapeutic intervention within the body.
- Device Description: The description details a physical implant made of titanium alloy, designed for surgical implantation.
- Lack of IVD Characteristics: The description does not mention any components or processes related to examining specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The GC Aadva Implant System is a medical device used within the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
I. Nonclinical Data Bench testing that studied the solubility, the corrosion and electrochemical properties of the metals, the cytotoxicity, and the fatigue of the GC Aadva Implant System was conducted. Testing indicated that Ti-6Al-4V alloy is estimated to be a corrosion resistant material and not cytotoxic. Furthermore, testing indicated that Ti-6Al-4V ELI alloy has acceptable strength according to the fatigue test results. Additionally, the packaging system for sterilized products and non-sterile components of GC Aadva Implant System is the same as that of JNE Implant System (K072425) in constituent materials and the structure, which has been validated according to ISO 11607-1. Animal testing that studies titanium alloy's suitability for surgical 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 the compatibility of the GC Aadva Implant System to bone tissue. Results indicate that Ti-6Al-4V ELI alloy is compatible to bone 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 nonclinical data indicating that the new device is safe and effective for its intended use and performs as well or better than predicate device. Performance testing data indicates that the new device is safe and effective for its intended use and performs as well or better than predicate device. Specifically, testing demonstrates that component material in the subject device is the same as the component material in a predicate device, and conforms to relevant ISO and ASTM standards. Bench testing 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 demonstrates that this device meets the mechanical properties recommendations by FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K072425, K971196, K002513, K033984
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
5. 510(k) Summary
| Submitter/Contact
Person | H. Carl Jenkins
The Wood Burditt Group
DEC - 6 2010
FDA Regulatory Counseling
10 E. Scranton Avenue, Suite 201
Lake Bluff, IL 60044
(ph) (847) 234-7500 x 205
(fax) (847) 574-0728
(email) hcjenkins@woodburditt.com |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | GC America, Inc.
3737 W. 127th Street
Alsip, IL 60803
800.323.3386 x4042
708.897.4042
708.897.4031 (fax) |
| Manufacturer | GC CORPORATION.
76-1 HASUNUMA-CHO,
ITABASHI-KU
TOKYO 174-8585 JAPAN |
| Sterilization Facility | RADIA INDUSTRY CO., LTD
168 OOYAGI, TAKASAKI
GUNNMA 370-0072 JAPAN |
| Device Name | GC Aadva Implant System |
| Common Name | Root-form Endosseous Dental Implant and Endosseous
Dental Implant Abutment |
| Classification | Class II
Procode DZE
Regulation: 21 CFR 872.3640 |
- 510(k) Summary
-0
1
| Identification of
Predicates and Summary
of Substantial
Equivalence | The GC Aadva Implant System is substantially equivalent
with respect to the intended use, design, risks, device
characteristics and performance aspects to numerous cleared
devices, including: |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) / Product / Manufacturer |
| | - K072425 / JNE IMPLANT SYSTEM / GC
AMERICA, INC. |
| | - K971196 / ENDOPORE ENDOSSEOUS DENTAL
IMPLANT SYSTEM / INNOVA CORP. |
| | - K002513 / ASTRA TECH IMPLANTS - DENTAL
SYSTEM / ASTRA TECH, INC. |
| | - K033984 / STRAUMANN DENTAL IMPLANT
SYSTEM / INSTITUT STRAUMANN AG |
| | The GC Aadva Implant System is comparable to the GC JNE
Implant System (K072425) in technological characteristics.
More specifically, the GC Aadva Implant System and the GC
JNE Implant System have the same component material,
chemical composition, body type, design shape, engaging
method, implant surface treatment and dimensions (lengths
and diameters). The GC Aadva Implant System and GC JNE
Implant System also have the same indications for use. |
| 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. |
| Intended Use and
Indications | 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. |
| Performance Testing | I. Nonclinical Data
Bench testing that studied the solubility, the corrosion and
electrochemical properties of the metals, the cytotoxicity, and
the fatigue of the GC Aadva Implant System was conducted.
Testing indicated that Ti-6Al-4V alloy is estimated to be a
corrosion resistant material and not cytotoxic. Furthermore,
testing indicated that Ti-6Al-4V ELI alloy has acceptable
strength according to the fatigue test results.
Additionally, the packaging system for sterilized products and
non-sterile components of GC Aadva Implant System is the
same as that of JNE Implant System (K072425) in constituent
materials and the structure, which has been validated
according to ISO 11607-1.
Animal testing that studies titanium alloy's suitability for
surgical 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 the
compatibility of the GC Aadva Implant System to bone tissue.
Results indicate that Ti-6Al-4V ELI alloy is compatible to
bone 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 nonclinical
data indicating that the new device is safe and
effective for its intended use and performs as
well or better than predicate device. | |
| Performance testing data indicates that the new device is safe
and effective for its intended use and performs as well or
better than predicate device. Specifically, testing demonstrates
that component material in the subject device is the same as
the component material in a predicate device, and conforms to
relevant ISO and ASTM standards. Bench testing 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
demonstrates that this device meets the mechanical properties
recommendations by FDA. | |
- 510(k) Summary
Page 5.2 of 5.4
2
3
4
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.
5
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
6
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 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.
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