(137 days)
The Cotec Dental Implant 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. This system is not intended for immediate loading.
Cotec Dental Implant System is composed of two types of fixtures, internal and submerged and abutments. The sizes of the fixtures in both internal and submerged type are identical, and made of titanium meta! intended to be surgically placed in the bone of the upper or lower jar arches. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. This system is made from pure titanium, and the surface treatment of fixtures is done with R.B.M. whereas abutments are not surface treated. The submerged type implant has an internal morse tapered connection with abutment for stronger engaging and dispersed stress distribution. This means that marginal bone can be perfectly preserved for safety in long term use. There are two types of submerged implant, straight and tapered type. Fixture diameter is Ø3.8, Ø4.2, Ø4.7, Ø5.2mm and the length is 8.0, 10.0, 12.0, 14.0mm. Fixture and cover screw are made of CP, Ti, Gr4 (ASTM-F67). The abutment is made of Ti6Al4V,ELI(ASTM-F136), and its diameters are 3.8 - 5.2 mm and the length is 5.5 -- 7.5mm.
The provided text is a 510(k) summary for the Cotec Dental Implant System. It describes the device's technical specifications, intended use, and claims substantial equivalence to predicate devices (SQ IS System and SQ IT System by Neobiotech Co., Ltd.). The document outlines various performance tests conducted to demonstrate the safety and effectiveness of the device.
Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Purpose of Test) | Reported Device Performance |
|---|---|
| Acute systematic toxicity (safe without any systematic toxicity) | Test samples are safe without having any systematic toxicity. |
| Appearance (no fracture, deformation, crack) | No fracture, deformation, crack has been found. Test samples are safe. |
| Cytotoxicity (safe to be used) | The test samples are indicated to be safe to be used. |
| Intracutaneous reactivity (safely acceptable rate for intracutaneous reactivity) | Test samples are proved to be safely acceptable rate for intracutaneous reactivity. |
| Pyrogen test (safe with higher than body temperature) | This test proved that the test samples are safe with higher than body temperature. |
| Sensitization test (no indications of erythema or oedema on guinea pig skin) | Test samples are proved to be safe with having no indications of erythema or oedema on guinea pig skin. |
| Sterility test (no indications of bacterial activity) | No indications of bacterial activity, thus the test samples are proved to be safe to be used. |
| Overall safety and effectiveness (as safe and effective as predicate devices, no new safety/effectiveness questions) | Substantially equivalent to predicate devices, demonstrating safety and effectiveness; differences do not raise new questions. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document refers to "test samples" for each test but does not specify the exact number, quantity, or characteristics (e.g., number of implant fixtures, specific sizes tested) of the samples used for any of the individual performance studies.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that the tests were "conducted."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. The studies described (toxicity, appearance, cytotoxicity, etc.) are laboratory-based performance and biocompatibility tests, not clinical studies requiring expert interpretation of medical images or patient outcomes to establish ground truth in the same way an AI-driven diagnostic would. Therefore, the concept of "experts establishing ground truth" in this context is not relevant.
4. Adjudication Method for the Test Set:
- Not Applicable. As these are laboratory performance tests, there is no "adjudication method" involving multiple reviewers to establish ground truth as would be seen in clinical or image-based diagnostic studies. The results would be objectively measured or observed based on established laboratory protocols and standards (e.g., ASTM standards for material properties, specified test methods for biocompatibility).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not conducted. This device is a dental implant system (a physical medical device), not a diagnostic algorithm or AI system that assists human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not relevant here.
6. Standalone Performance Study:
- Yes (inherently). The performance studies listed (acute systematic toxicity, appearance, cytotoxicity, intracutaneous reactivity, pyrogen, sensitization, sterility) are all standalone tests of the device itself, performed without human-in-the-loop assistance. The results directly assess the intrinsic properties and biological safety of the Cotec Dental Implant System.
7. Type of Ground Truth Used:
- The "ground truth" for the tests performed is derived from the established scientific and regulatory standards for medical device biocompatibility and performance. For example:
- Biocompatibility tests (Toxicity, Cytotoxicity, Reactivity, Pyrogen, Sensitization): Ground truth is defined by the absence of adverse biological reactions as per ISO 10993 series of standards (which typically underpin such tests, though not explicitly cited here, it's implied by the FDA guidance document reference) and specific pass/fail criteria for each test according to regulatory guidelines.
- Material properties and physical integrity (Appearance): Ground truth is based on visual and physical inspection against predefined quality standards (e.g., absence of visible defects).
- Sterility: Ground truth is the absence of microbial growth as determined by standard microbiological culture methods.
8. Sample Size for the Training Set:
- Not applicable. The Cotec Dental Implant System is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development. The device's design and manufacturing are based on established engineering principles and material science, not trained data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for this physical device, this question is irrelevant. The "ground truth" for the design and manufacturing of the device is rooted in engineering specifications, material standards (e.g., ASTM-F67, ASTM-F136), and regulatory requirements for dental implants.
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Cotec Dental Implant System
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Cotec Implant Co., Ltd.
KIDDSII
510(K) Summary
JUL - 9 2010
Submitter Cotec Implant Co., Ltd. Choi Ju Won 24-11 A, Sungju-Dong Changwon-City Gyeongnam, 641-120, S. Korea Phone: 88-55-275-9695 Fax: 88-55-289-9695
US Agent / Official Contact Kodent Inc. Joyce Bang 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Email: kodentinc@gmail.com Phone: 562-404-8466 Fax: 562-404-2757
Device Information
Trade Name: Cotec Dental Implant System
Common Name: Endosseous Dental Implant
Classification Name: Implant, Endosseous, Root-Form
Product Code: DZE
Regulation Number: 872.3640
Device Class: Class II
Date Prepared: April 30, 2010
General Description
Cotec Dental Implant System is composed of two types of fixtures, internal and submerged and abutments. The sizes of the fixtures in both internal and submerged type are identical, and made of titanium meta! intended to be surgically placed in the bone of the upper or lower jar arches. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. This system is made from pure titanium, and the surface treatment of fixtures is done with R.B.M. whereas abutments are not surface treated.
The submerged type implant has an internal morse tapered connection with abutment for stronger engaging and dispersed stress distribution. This means that marginal bone can be perfectly preserved for safety in long term use. There are two types of submerged implant, straight and tapered type. Fixture diameter is Ø3.8, Ø4.2, Ø4.7, Ø5.2mm and the length is 8.0, 10.0, 12.0, 14.0mm. Fixture and cover screw
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are made of CP, Ti, Gr4 (ASTM-F67). The abutment is made of Ti6Al4V,ELI(ASTM-F136), and its diameters are 3.8 - 5.2 mm and the length is 5.5 -- 7.5mm.
Indication for Use
The Cotec Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is not intended for immediate loading.
Predicate Devices & Comparison
The subject device is substantially equivalent to the following predicate devices:
Testing and other comparisons have established that the subject of Cotec Dental Implant System is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate devices of the type currently marketed in the U.S.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| 510(K) Number | N / A | K090825 | K090527 |
| Device Name | Cotec Dental Implant System | SQ IS System | SQ IT System |
| Manufacturer | Cotec Implant Co., Ltd. | Neobiotech Co., Ltd. | Neobiotech Co., Ltd. |
| Indications for Use | Mandible and MaxillaEndosseous Dental Implant &Accessories | Mandible and MaxillaEndosseous DentalImplant & Accessories | Mandible and MaxillaEndosseous DentalImplant &Accessories |
| Design | Flat shoulder Internal and flatshoulder submerged ImplantDesign with a narrower shapetowards the bottom | Similar to flat shouldersubmerged implantdesign with a narrowershape towards the bottom | Similar to flatshoulder internalimplant design with anarrower shapetowards the bottom |
| Endosseous Implant Material | CP. Ti. Gr. 4ASTM-F67 | CP. Ti. Gr. 4ASTM-F67 | CP. Ti. Gr. 4ASTM-F67 |
| Implant Sterile | Yes | Yes | Yes : |
| Implant Sterilization Method | Gamma | Gamma | Gamma |
| Abutment and cover screwsterilization method | Non-sterile | Non-sterile | Non-sterile |
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| Surface Treatment | RBM (Resorbable BlastingMedia) | RBM (ResorbableBlasting Media) | RBM (ResorbableBlasting Media) | |
|---|---|---|---|---|
| Implant | Diameters | 3.8 - 5.2 mm | 3.5 - 8.0 mm | 3.5 - 6.0 mm |
| Lengths | 8 - 14 mm | 7 - 15 mm | 8 - 15 mm | |
| Abutment | Diameters | 3.8 - 5.2mm | 3.5 - 8.0mm | 3.5 - 6.0mm |
| Lengths | 5.5 - 7.5mm | 4.0 - 8.0mm | 4.0 - 8.5mm | |
| Cover screw | Diameters | 3.32mm | 3.19 - 3.43mm | 3.5 - 3.6mm |
| Cufflengths | 3.0mm | 3.0mm | 3.0mm | |
| Attachments | Various abutments andcomponents | Various abutments andcomponents | Various abutmentsand components | |
| AbutmentMaterial | Ti6Al4V, ELI,ASTM-F136 | Ti6Al4V, ELI,ASTM-F136 | Ti6Al4V, ELI,ASTM-F136 | |
| Cover ScrewMaterial | CP. Ti. Gr. 4ASTM-F67 | CP. Ti. Gr. 4ASTM-F67 | CP. Ti. Gr. 4ASTM-F67 | |
| Product Code | DZE | DZE | DZE |
Performance Data and
We have conducted the following tests. All of the data consistent with the recommendations in the FDA guidance document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutnents, May 12, 2004. The following tests have demonstrated that there is substantial equivalence in the performance, safety and effectiveness between the Cotec Implant System and the referenced predicate devices and it has proved that the Cotec implant system meets its predefined acceptance criteria and performs in accordance with its intended use. Test samples refer to the devices included in this system.
- · Acute systematic toxicity test: This test proved the test samples are safe without having any systematic toxicity.
- · Appearance test: this test conducted by macroscopic examination of external appearance of test samples. No fracture, deformation crack has been found. This test proved the test samples are safe.
- · cytotoxicity test: As a result for this test, the test samples are indicated to be safe to be used.
- · intracutaneous reactivity test : Based on the collected data, this test samples are proved to be safely acceptable rate for intracutaneous reactivity.
- pyrogen test: As a result, this test proved that the test samples are safe with higher than body temperature.
- Sensitization test: In this study, the test samples are proved to be safe with having no indications of erythema or oedema on guinea pig skin.
- · Sterility test: To examine the activity of bacteria, this test has been conducted. As a result, there were no indications of bacterial activity, thus the test samples are proved to be safe to be used.
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Safety and Effectiveness
This device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device, and it can be demonstrated that the device is as safe and effective as the predicate device, and that the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device. It has been shown in this 510(k) submission that the differences between the Cotec Dental Implant System and the predicate devices do not raise any questions regarding its safety and effectiveness. The Cotec Dental Implant system, as designed and manufactured, is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent to the referenced predicate devices.
Conclusion
The Cotec Dental Implant System, subject of this submission, constitutes a safe, reliable and effective medical device, meeting all the declared requirements of its intended use. Device presents no adverse health effects or safety risks to patients when used as intended. The Cotec Dental Implant System has the same intended use and fundamental scientific technology as its predicate devices - the SQ IS System (K090825) and SQ IT System (K090527) by Neobiotech Co., Ltd. Therefore, Cotec Dental Implant System and its predicate devices are believed to be substantially equivalent.
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Image /page/4/Picture/1 description: The image is a circular seal or logo. The seal contains the symbol of the United States Department of Health and Human Services, which is a stylized eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cotec Implant Company Limited C/O Ms. Joyce Bang Consultant Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670
JUL - 9 2010
Re: K100511
Trade/Device Name: Cotec Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 24, 2010 Received: June 25, 2010
Dear Ms. Bang:
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- Ms. Bang
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/Resourcesfor You/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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Indications for Use
510(k) Number (if known): K100511
Device Name: Cotec Dental Implant System
Indications for Use: The Cotec Dental Implant 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. This system is not intended for immediate loading.
Prescription Use × (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)
| for NSR | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices |
| 510(k) Number: | K100511 |
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§ 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.