(204 days)
Not Found
No
The 510(k) summary describes a standard dental implant system and does not mention any AI or ML components or functionalities.
No.
The primary purpose of the dental implant system is to provide structural support for prosthetic devices and restore chewing function, not to treat or cure a disease or condition. While it improves function, it's a restorative device rather than a therapeutic one in the medical sense.
No
This device is a dental implant system designed to replace teeth and restore chewing function. It is a prosthetic device for treatment, not a diagnostic one.
No
The device description clearly outlines physical components made of titanium, titanium alloy, and stainless steel, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Anker Dental Implant System: The description clearly states that the Anker Dental Implant System is "intended to be surgically placed in the bone of the upper or lower jaw arches." This is a device that is implanted into the body, not used to test samples taken from the body.
The device description and intended use clearly indicate it's a surgically implanted medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Anker Dental Implant System 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, and to restore the patient's chewing function. It is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
Anker Dental Implant System consists of fixture, abutment (healing abutment, fixed abutment, dual abutment, angle abutment, o-ring abutment, temporary abutment) and cover screw. Fixture is made of pure titanium (grade IV) and its surface was treated by SLA (Sand-blasted, Large grit, Acid-etched) process. Diameters of fixtures are including 3.4 to 5.0 mm and lengthes are including 7.0 to 15.0 mm. Most abutments are made of titanium alloy and their diameters are including 4.0 to 7.0 mm. Temporary abutment is made of SUS316 stainless steel instead of titanium alloy. All products are sterilized as finished products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the 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)
Non-clinical test was used to support the decision of safety and effectiveness.
Non-clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of the non-clinical testing demonstrate that the Anker Dental Implant System is substantially equivalent to the predicate devices.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for Alliance Global Technology Co. Ltd. The logo features the word "Alliance" in large, bold letters, with the words "Global Technology Co. Ltd" in smaller letters underneath. Above the word "Alliance" is a graphic of a globe. The logo is black and white.
510(k) SUMMARY
Anker Dental Implant system
Company Name: Alliance Global Technology Co., Ltd. 2F., No.92, Luke 5th Rd., Luzhu Dist., Kaohsiung City 821, Taiwan (R.O.C.) Telephone: +886-7-695-6688 Fax: +886-7-695-5329
Contact Person: Ms. Yayuan Chang Telephone: +886-7-695-6688 Fax: +886-7-695-5329 E-mail: ketty@anchorfast.com.tw
Date prepared: Sep 12nd, 2013
Trade Name: Anker Dental Implant System
Common Name: Dental Implant
Classification Name: Root-form endosseous dental implant
Device Classification: Class II
Regulation Number: 21 CFR 872.3640
Panel: Dental
Product Code: DZE
Predicate Device:
(1)Predicate Device Name: Dentium Co., Ltd Implantium Manufacturer: Dentium Company Limited 510(k) Number: K041368 (2)Predicate Device Name: Osstem GS-III system Manufacturer: OSSTEM Implant Co., Ltd.
510(k) Number: K091208
510(k) K131165-Anker Dental Implant System Section 5 - Page 5-1
NOV 14 2019
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Image /page/1/Picture/0 description: The image shows the logo for ALLIANCE GLOBAL TECHNOLOGY CO. LTD. The logo features the word "ALLIANCE" in large, bold, black letters. Above the word "ALLIANCE" is a graphic of a globe. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO. LTD." in smaller, black letters.
Device Description:
Anker Dental Implant System consists of fixture, abutment (healing abutment, fixed abutment, dual abutment, angle abutment, o-ring abutment, temporary abutment) and cover screw. Fixture is made of pure titanium (grade IV) and its surface was treated by SLA (Sand-blasted, Large grit, Acid-etched) process. Diameters of fixtures are including 3.4 to 5.0 mm and lengthes are including 7.0 to 15.0 mm. Most abutments are made of titanium alloy and their diameters are including 4.0 to 7.0 mm. Temporary abutment is made of SUS316 stainless steel instead of titanium alloy. All products are sterilized as finished products.
Indications for Use:
Anker Dental Implant System 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, and to restore the patient's chewing function. It is intended for delayed loading.
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Image /page/2/Picture/0 description: The image shows the logo for ALLIANCE GLOBAL TECHNOLOGY CO., LTD. The word "ALLIANCE" is in large, bold, black letters. Below that is the text "GLOBAL TECHNOLOGY CO., LTD." in smaller, thinner, black letters. Above the word "ALLIANCE" is a black and white image of a globe.
Substantial Equivalence:
| Item | | Anker Dental Implant
System | Osstem GS-III system | Dentium Co., Ltd
Implantium |
|------|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Classification | Class II | Class II | Class II |
| 2. | Code or
Federal
Regulations | 872.3640 | 872.3640 | 872.3640 |
| 3. | 510K No. | K131165 | K091208 | K041368 |
| 4. | Design | Image: Anker Dental Implant | Image: Osstem GS-III system | Image: Dentium Co., Ltd Implantium |
| 5. | Intended Use | Anker Dental Implant
System 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, and to restore
the patient's chewing
function. It is intended for
delayed loading. | The GS III System is
indicated for use in
partially or fully
edentulous mandibles and
maxillae, in support of
single or multiple-unit
restorations including;
cemented retained, screw
retained, or overdenture
restorations, and terminal
or intermediate abutment
support for fixed
bridgework. The GS III
System is for single and
two stage surgical
procedures. It is not for
immediate load. | The Dentium Co., Ltd
Implantium 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, and to
restore the patient's
chewing function. |
| 6. | Body
Diameter | 3.4mm, 3.5mm, 3.8mm,
4.0mm, 4.3mm, 4.5mm,
4.8mm, 5.0mm | 3.7 mm,4.2 mm,4.6 mm,
5.1mm | 3.4mm, 3.8mm, 4.3mm,
4.8mm |
| 7. | Length | 7mm, 8 mm, 8.5mm, 10mm,
11.5mm, 12mm, 13mm,
14mm,
15mm | 7 mm, 8.5 mm, 10mm,
11.5 mm, 13mm, 15mm | 8 mm, 10 mm, 12mm,
14mm |
| 8. | Surface | S.L.A. (Sand-blasted, Large
grit, Acid-etched surface) | RBM (Resorbable
Blasting Media) | S.L.A. (Sandblasting with
large grit and acid
etching) |
| 9. | Sterilization | y-ray (Radiation) | y-ray (Radiation) | y-ray (Radiation) |
| 10. | Material | Titanium | Titanium | Titanium |
| 11. | Abutment
angulations | 0. 17 deg | 0. 17 deg | 0. 15, 25 deg |
| 12. | Material of
Abutments | Titanium Vanadium Alloy | Titanium Vanadium Alloy | Titanium Vanadium Alloy |
510(k) K131165-Anker Dental Implant System Section 5 - Page 5-3
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Image /page/3/Picture/0 description: The image shows the logo for ALLIANCE GLOBAL TECHNOLOGY CO., LTD. The word "ALLIANCE" is written in large, bold, black letters. Above the word "ALLIANCE" is a black and white image of a globe. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD" in smaller, black letters.
Comparing to the predicate devices, Dentium Co., Ltd Implantium (510K No. K041368) and Osstem GS-III system (510K No. K091208), Anker Dental Implant System is equivalent in surface treatment, intended use, method of operation, material and design.
Non-clinical Testing:
Non-clinical test was used to support the decision of safety and effectiveness.
Non-clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of the non-clinical testing demonstrate that the Anker Dental Implant System is substantially equivalent to the predicate devices.
| Testing Item | Reference |
|---|---|
| Compressive forces and Fatigue tests | ISO14801 |
| Compatibility test of dental implant/abutment | |
| interface | N/A |
| Corrosion test | ASTM G3-89 |
| Residual of Acidic Substances Test | ISO10993-12 |
| Biocompatibility test | ISO10993-3 |
| ISO10993-5 | |
| ISO10993-6 | |
| ISO10993-10 | |
| ISO10993-11 | |
| Pharmacopeia US | |
| OECD guideline #473 |
Overview for all non-clinical testing:
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Image /page/4/Picture/0 description: The image shows the logo for ALLIANCE GLOBAL TECHNOLOGY CO., LTD. The word "ALLIANCE" is written in large, bold, black letters. Above the word "ALLIANCE" is a black and white image of the earth. Below the word "ALLIANCE" is the text "GLOBAL TECHNOLOGY CO., LTD" in smaller, black letters.
| OECD guideline #474 | |
|---|---|
| Sterilization Validation of Gamma Irradiation | ISO11137-1 |
| Shelf life Validation | ASTM F88/F88M-09 |
| ASTM F1140-07 | |
| ASTM F1929-98 | |
| ISO11737-2 |
Clinical Testing:
Non-clinical test was used to support the decision of safety and effectiveness.
Conclusion:
The evaluation of the Anker Dental Implant system does not raise any additional . concerns regarding safety and effectiveness and Anker Dental Implant system may therefore be considered substantially equivalent to their predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
November 14, 2013
Alliance Global Company Technology Company, Limited Ms. Yayuan Chang Manager 2F., No.92, Luke 5th Road Luzhu District, Kaohsiung City 82151 TAIWAN (R.O.C.)
Re: K131165
Trade/Device Name: Anker Dental Implant System Regulation Number: 21 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 4, 2013 Received: October 7, 2013
Dear Ms. Chang:
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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
MaryFDAmer-S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K131165
Device Name: Anker dental implant system
Indications for Use:
Anker Dental Implant System 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, and to restore the patient's chewing function. It is intended for delayed loading,
Prescription Use ____________ Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (2) 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)
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510(k) K131165-Anker Dental Implant System Section 4 - Page 4-1
Andrew I. Steen -S - . - . 2013.11.13 11:25:52 -05'00'