(264 days)
"ComMed" Series Dental Implant System is intended for surgical placement in the maxilla or mandible to provide for prosthetic attachment to restore a patient's chewing function. "ComMed" Series Dental Implants are intended only for delayed loading.
The Chang Gung "ComMed" Series Dental Implant System includes threaded root-form endosseous dental implants (fixtures) and dental implant abutments (healing abutment, standard abutment, angle abutment). The implants are cylindrical and tapered posts made of Grade 4 Pure Titanium. The abutments are made of Ti6Al4V. The system features an internal hex with Morse Taper 8° connection, platform switching, and fine thread in the neck. Various diameters (3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm) and lengths (10, 11, 12, 13, 14, 15, 16 mm) are available for the implants. The surface treatment is blasted with Aluminum Oxide and Acid Etched, and it is also anodized. Implants are sterilized by Gamma irradiation, and abutments are sterilized by moist heat sterilization before use by clinicians.
The provided text describes the Chang Gung "ComMed" Series Dental Implant System and its clearance through the 510(k) pathway, which establishes substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating that the new device is as safe and effective as existing ones, rather than providing extensive de novo clinical trials typical for novel medical devices. Therefore, the information provided focuses on non-clinical testing rather than studies involving human subjects, AI performance, or expert ground truth.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in numerical terms for the non-clinical tests. Instead, it refers to conformity with relevant ISO and ASTM standards. The reported device performance is that it met these standards, supporting substantial equivalence.
| Test Category | Test Performed | Relevant Standard(s) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | In vitro cytotoxicity study, Intracutaneous reactivity study, Skin sensitization study, Acute systemic toxicity, Pyrogenicity study, 14-day repeated dose systemic toxicity study, In vitro haemolysis study, In vitro bacterial reverse mutation (AMES) study, In vitro chromosome aberration study, In vitro mammalian cell gene mutation study, Bone formation and histological study (for Implant/Abutment) | ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-4, ISO 10993-3, ISO 10993-6 | Conformed to relevant ISO standards, supporting biocompatibility. (Implied: accepted by FDA) |
| Static and Dynamic Fatigue Loading | Static and dynamic fatigue test (for Implant and standard abutment) Static and dynamic fatigue test (for Implant and angle abutment) | ISO 14801 | Conformed to ISO 14801, indicating mechanical durability. (Implied: accepted by FDA) |
| Sterilization Validation | Sterilization validation of Gamma irradiation (for Implant) Moist heat validation - microbiological performance qualification (for Abutment) | ISO 11737-1, ISO 11737-2, ISO 17665-1 | Conformed to relevant ISO standards, ensuring sterility. (Implied: accepted by FDA) |
| Packaging Shelf Life Validation | Burst and creep tests, Dye penetration test, Seal peel test, Microbial ranking test (initially and after 2, 3, and 5 years of accelerated aging) | ASTM F1140, ASTM F1929, ASTM F88/F88M, ASTM F1608, ASTM F1980 | Conformed to relevant ASTM standards, ensuring packaging integrity and shelf life. (Implied: accepted by FDA) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text. The non-clinical testing described typically involves specific numbers of samples (e.g., implants, abutments, packaging units) tested in a lab setting, but these quantities are not detailed.
- Data Provenance: The tests are non-clinical, meaning they are lab-based or in-vitro/in-vivo animal studies (for biocompatibility in some cases, though specific animal models are not detailed). The testing was conducted to support the substantial equivalence submission for a device manufactured by Chang Gung Medical Technology Co., Ltd. in Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this 510(k) submission. The "test set" here refers to the physical devices and materials subjected to non-clinical tests, not a dataset requiring human expert annotation for ground truth. The evaluation of compliance with standards is done by testing laboratories and regulatory bodies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept typically refers to how disagreements among human reviewers (e.g., radiologists) are resolved in clinical studies or AI evaluations. For engineering and biocompatibility testing, the "adjudication" is based on whether the test results meet the specified criteria of the referenced standards.
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
Not applicable. This device is a dental implant system (hardware), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI performance metrics are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's non-clinical testing is adherence to the specified performance characteristics as defined by international standards (ISO, ASTM) for mechanical strength, biocompatibility, sterility, and packaging integrity.
8. The sample size for the training set
Not applicable. Training sets are relevant for machine learning algorithms, which this device is not.
9. How the ground truth for the training set was established
Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2015
Chang Gung Medical Technology Co., Ltd. Mr. Chao-Chun Chiu Manager 11F., No. 201-4, DungHua North Rd., Song Shan District Taipei City, Taiwan 10508 REPUBLIC OF CHINA
Re: K142751 Trade/Device Name: Chang Gung "ComMed" Series Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 11, 2015 Received: May 13, 2015
Dear Mr. Chiu:
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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K142751
Device Name
Chang Gung "ComMed" Series Dental Implant System
Indications for Use (Describe)
"ComMed" Series Dental Implant System is intended for surgical placement in the maxilla or mandible to provide for prosthetic attachment to restore a patient's chewing function. "ComMed" Series Dental Implants are intended only for delayed loading.
Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Chang Gung Medical Technology Co., Ltd.
Chapter 4 510(k) Summary
| Type of Submission | Original Application - Traditional 510(k) |
|---|---|
| Device Name | Chang Gung "ComMed" SeriesDental Implant System |
| Validated Date | 2015.06.12 |
| Version | 1.4 |
11F., No. 201-4, Dunghua N. Rd., Song Shan Dist. Taipei City, TAIWAN 10508 Tel: +886 2 8712 2948 Fax: +886 2 2514 0620
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4.1 Applicant Information
| Type of Submission | Original Application- Traditional 510(k) |
|---|---|
| Applicant Name | Chang Gung Medical Technology Co., Ltd. |
| Address | Office : Chang Gung Medical Technology Co., Ltd.11F., No. 201-4, Dunghua N. Rd., Song Shan Dist.Taipei City, TAIWAN 10508Factory: Chang Gung Medical Technology Co., Ltd. LinkouFactory2F., No. 118, Nanlin Rd., Taishan Dist., New TaipeiCity 24352, Taiwan (R.O.C.) |
| Phone | +886 2 8712 2948 |
| Fax | +886 2 2514 0620 |
| Contact Person | Heng-Liang Liu |
| Contact Title | Project Manager |
| Contact E-mail | hlliu@cgmc.com.tw |
4.2 Device Description
| Common Name | Dental Implant |
|---|---|
| Trade Name | Chang Gung "ComMed" Series Dental Implant System |
| Classification Name | Implant, Endosseous, Root-form |
| Regulation Number | 872.3640 |
| Product Code | DZE, NHA |
| Device Class | Class II |
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4.3 Technological Characteristics of Device
| Product Name | Chang Gung "ComMed" Series Dental Implant System |
|---|---|
| Regulation Number | 872.3640 |
| Product Code | DZE, NHA |
| Intended Use | "ComMed" Series Dental Implant System is intendedfor surgical placement in the maxilla or mandible toprovide means for prosthetic attachment to restore apatient' s chewing function. "ComMed" Series DentalImplants are intended only for delayed loading. |
| Material | Implant: Grade 4 Pure TitaniumAbutment: Ti6Al4V |
| Connection | Internal Hex with Morse Taper 8° |
| Platform Switching | YES |
| Fine thread in Neck | YES |
| Diameter (mm) | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 |
| Length (mm) | 10, 11, 12, 13, 14, 15,16 |
| Angle Abutment | YES (15°) |
| Surface Treatment | Blasted with Aluminum Oxide and Acid Etched. |
| Anodized Treatment | YES |
| Sterilization method | Implant : Gamma irradiationAbutment : Moist heat sterilization before use byclinicians. |
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Components
| Name | Function | Accessories |
|---|---|---|
| Standard Implant(Fixture) | A cylindrical and tapered post thatserves as a substitute for the tooth root. | Cover ScrewMountMount Screw |
| Healing Abutment | Attached to the fixture for gingivalforming. | N/A |
| Standard Abutment | A connector built into the top of thefixture to straightly attach the implant tothe replacement tooth. | Abutment Screw |
| Angle Abutment | A connector built into the top of thefixture to obliquely attach the implant tothe replacement tooth. | Abutment Screw |
| Accessories | ||
| Cover Screw | A screw placed on the superior part of afixture during osseointegration period.The Cover Screw size depends on thecorresponding Standard Implant. | N/A |
| Mount | A temporary part to connect fixture todriver for placement. The Mount sizedepends on the corresponding StandardImplant. | N/A |
| Mount Screw | Connection implant with mount. TheMount Screw size depends on thecorresponding Standard Implant. | N/A |
| Abutment Screw | Connection implant with standardabutment or angle abutment. TheAbutment Screw size depends on thecorresponding Abutment. | N/A |
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Specification
- Standard Implant : .
| Model Type | Model No. | Ø/L(mm) | Model Type | Model No. | Ø/L(mm) | Model Type | Model No. | Ø/L(mm) |
|---|---|---|---|---|---|---|---|---|
| UTAA3510 | Ø 3.5 / L 10.0 | UTAA4510 | Ø 4.5 / L 10.0 | UTAA5510 | Ø 5.5 / L 10.0 | |||
| UTAA3511 | Ø 3.5 / L 11.0 | UTAA4511 | Ø 4.5 / L 11.0 | UTAA5511 | Ø 5.5 / L 11.0 | |||
| UTAA3512 | Ø 3.5 / L 12.0 | UTAA4512 | Ø 4.5 / L 12.0 | UTAA5512 | Ø 5.5 / L 12.0 | |||
| UTAA3513 | Ø 3.5 / L 13.0 | UTAA4513 | Ø 4.5 / L 13.0 | UTAA5513 | Ø 5.5 / L 13.0 | |||
| UTAA3514 | Ø 3.5 / L 14.0 | UTAA4514 | Ø 4.5 / L 14.0 | UTAA5514 | Ø 5.5 / L 14.0 | |||
| UTAA3515 | Ø 3.5 / L 15.0 | UTAA4515 | Ø 4.5 / L 15.0 | UTAA5515 | Ø 5.5 / L 15.0 | |||
| Standard | UTAA3516 | Ø 3.5 / L 16.0 | Standard | UTAA4516 | Ø 4.5 / L 16.0 | Standard | UTAA5516 | Ø 5.5 / L 16.0 |
| Implant | UTAA4010 | Ø 4.0 / L 10.0 | Implant | UTAA5010 | Ø 5.0 / L 10.0 | Implant | UTAA6010 | Ø 6.0 / L 10.0 |
| UTAA4011 | Ø 4.0 / L 11.0 | UTAA5011 | Ø 5.0 / L 11.0 | UTAA6011 | Ø 6.0 / L 11.0 | |||
| UTAA4012 | Ø 4.0 / L 12.0 | UTAA5012 | Ø 5.0 / L 12.0 | UTAA6012 | Ø 6.0 / L 12.0 | |||
| UTAA4013 | Ø 4.0 / L 13.0 | UTAA5013 | Ø 5.0 / L 13.0 | UTAA6013 | Ø 6.0 / L 13.0 | |||
| UTAA4014 | Ø 4.0 / L 14.0 | UTAA5014 | Ø 5.0 / L 14.0 | UTAA6014 | Ø 6.0 / L 14.0 | |||
| UTAA4015 | Ø 4.0 / L 15.0 | UTAA5015 | Ø 5.0 / L 15.0 | UTAA6015 | Ø 6.0 / L 15.0 | |||
| UTAA4016 | Ø 4.0 / L 16.0 | UTAA5016 | Ø 5.0 / L 16.0 | UTAA6016 | Ø 6.0 / L 16.0 |
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- Healing Abutment : .
| Model Type | Model No. | Specification | Model Type | Model No. | Specification |
|---|---|---|---|---|---|
| HealingAbutment | UTAB3501 | Ø 3.5mm / GH 1 | HealingAbutment | UTAB5001 | Ø 5.0mm / GH 1 |
| UTAB3503 | Ø 3.5mm / GH 3 | UTAB5003 | Ø 5.0mm / GH 3 | ||
| UTAB3505 | Ø 3.5mm / GH 5 | UTAB5005 | Ø 5.0mm / GH 5 | ||
| UTAB4001 | Ø 4.0mm / GH 1 | UTAB5501 | Ø 5.5mm / GH 1 | ||
| UTAB4003 | Ø 4.0mm / GH 3 | UTAB5503 | Ø 5.5mm / GH 3 | ||
| UTAB4005 | Ø 4.0mm / GH 5 | UTAB5505 | Ø 5.5mm / GH 5 | ||
| UTAB4501 | Ø 4.5mm / GH 1 | UTAB6001 | Ø 6.0mm / GH 1 | ||
| UTAB4503 | Ø 4.5mm / GH 3 | UTAB6003 | Ø 6.0mm / GH 3 | ||
| UTAB4505 | Ø 4.5mm / GH 5 | UTAB6005 | Ø 6.0mm / GH 5 |
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- Standard Abutment : .
| Model Type | Model No. | Specification | Model Type | Model No. | Specification |
|---|---|---|---|---|---|
| StandardAbutment | UTBA3501 | Ø 3.5mm / GH 1 | StandardAbutment | UTBA5001 | Ø 5.0mm / GH 1 |
| UTBA3503 | Ø 3.5mm / GH 3 | UTBA5003 | Ø 5.0mm / GH 3 | ||
| UTBA3505 | Ø 3.5mm / GH 5 | UTBA5005 | Ø 5.0mm / GH 5 | ||
| UTBA4001 | Ø 4.0mm / GH 1 | UTBA5501 | Ø 5.5mm / GH 1 | ||
| UTBA4003 | Ø 4.0mm / GH 3 | UTBA5503 | Ø 5.5mm / GH 3 | ||
| UTBA4005 | Ø 4.0mm / GH 5 | UTBA5505 | Ø 5.5mm / GH 5 | ||
| UTBA4501 | Ø 4.5mm / GH 1 | UTBA6001 | Ø 6.0mm / GH 1 | ||
| UTBA4503 | Ø 4.5mm / GH 3 | UTBA6003 | Ø 6.0mm / GH 3 | ||
| UTBA4505 | Ø 4.5mm / GH 5 | UTBA6005 | Ø 6.0mm / GH 5 |
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●
| Model Type | Model No. | Specification | Model Type | Model No. | Specification |
|---|---|---|---|---|---|
| Angle Abutment | UTBB3501 | Ø 3.5mm / 15°/ GH 1 | Angle Abutment | UTBB5001 | Ø 5.0mm / 15°/ GH 1 |
| UTBB3503 | Ø 3.5mm / 15°/ GH 3 | UTBB5003 | Ø 5.0mm / 15°/ GH 3 | ||
| UTBB3505 | Ø 3.5mm / 15°/ GH 5 | UTBB5005 | Ø 5.0mm / 15°/ GH 5 | ||
| UTBB4001 | Ø 4.0mm / 15°/ GH 1 | UTBB5501 | Ø 5.5mm / 15°/ GH 1 | ||
| UTBB4003 | Ø 4.0mm / 15°/ GH 3 | UTBB5503 | Ø 5.5mm / 15°/ GH 3 | ||
| UTBB4005 | Ø 4.0mm / 15°/ GH 5 | UTBB5505 | Ø 5.5mm / 15°/ GH 5 | ||
| UTBB4501 | Ø 4.5mm / 15°/ GH 1 | UTBB6001 | Ø 6.0mm / 15°/ GH 1 | ||
| UTBB4503 | Ø 4.5mm / 15°/ GH 3 | UTBB5001 | Ø 6.0mm / 15°/ GH 1 | ||
| UTBB4505 | Ø 4.5mm / 15°/ GH 5 | UTBB5003 | Ø 6.0mm / 15°/ GH 3 |
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| Subject Device | Predicate device | Reference device#1 | Reference device#2 | |
|---|---|---|---|---|
| 510(k)Number | - | K033984 | K073075 | K040807 |
| Indication foruse | "ComMed" SeriesDental ImplantSystem isintended forsurgicalplacement in themaxilla ormandible toprovide means forprostheticattachment torestore apatient'schewing function."ComMed" SeriesDental Implantsare intended onlyfor delayedloading. | The ITI DentalSystem implantsare forsingle-stage ortwo-stage surgicalprocedures. Theimplants areintended forimmediateplacement andfunction onsingle-toothand/or multipletooth applicationswhen goodprimary stability isachieved and withappropriateocclusal loading,to restore chewingfunction. Multipletooth applicationsmay be rigidlysplinted. In thecase ofedentulouspatients, 4 ormore implantsmust be used inimmediately | The FRIADENTImplant systemsare forsingle-stage ortwo-stage surgicalprocedures andcemented orscrew retainedrestorations. TheFRIADENT ImplantSystems areintended forimmediateplacement andfunction on singletooth and/ormultiple toothapplications whengood primarystability isachieved, withappropriateocclusal loading,in order to restorechewing function.Multiple toothapplications maybe splinted with abar. | The MIS DentalImplant System isindicated for usein surgical andrestorativeapplications forplacement in thebone of the upperor lower jaw toprovide supportfor prostheticdevices, such asartificial teeth, inorder to restorethe patient'schewing function. |
| loaded cases. | ||||
| Trade name | Chang Gung"ComMed " Series Dental ImplantSystem | STRAUMANNDENTAL IMPLANTSYSTEM | FRIADENT Implant MIS DENTALSystems - XiVE® SPlus DentalImplant System | IMPLANT SYSTEM |
| Material | Implant: Grade 4Pure TitaniumAbutment:Ti-6Al-4V | Implant: Grade 4Pure TitaniumAbutment: Grade4 Pure Titanium | Implant: Grade 2Pure TitaniumAbutment:Ti-6Al-4V / Grade2 Pure Titanium | Implant: Grade 4Pure TitaniumAbutment:Ti-6Al-4V |
| Connectiontype | Internal hex withMorse taper 8° | Internal hex withMorse taper | Internal hex | Internal hex withMorse taper,internal octa withMorse taper |
| Platformswitching | Yes | Yes | No | No |
| Micro-threadat implantneck | Yes | No | No | Yes |
| Diameter(mm) | 3.5, 4.0, 4.5, 5.0,5.5, 6.0 | 3.3~4.8 | 3.0~5.5 | 3.3~6.0 |
| Length (mm) | 10, 11, 12, 13, 14,15, 16 | 8~14 | 8~18 | 6~16 |
| Angleabutment | Yes (15°) | Yes (15°) | Yes (15°) | Yes (15°) |
| Surfacemodification | Blasted withaluminum oxideand acid etched | Blasted withaluminum oxideand acid etched | Blasted withaluminum oxideand acid etched | Blasted withaluminum oxideand acid etched |
| Anodizing | Yes | Yes | Yes | Yes |
| Sterilizationmethod | Gammairradiation | Gammairradiation | Gammairradiation | Gammairradiation |
4.4 Predicate and Reference Devices
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4.5 Substantial Equivalence
Substantially equivalence is claimed to the following legally marketed predicate device: STRAUMANN DENTAL IMPLANT SYSTEM (K033984) and reference device: FRIADENT Implant Systems – XiVE® S Plus Dental Implant System (K073075) and MIS DENTAL IMPLANT SYSTEM (K040807). The above comparison table lists the primary technological characteristics and specifications that are pertinent to Dental Implant Systems. Based on the comparison analysis, the proposed device is identical to the predicate and reference devices in terms of intended use, materials, surface treatment, sterilization method, and comparable technological characteristics and general design features.
All minor differences in design features (connection type, platform switching and micro-thread at implant neck) exist between the subject and the predicate and reference devices have been evaluated per the testing described in section 4.6 (non-clinical testing) following the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments" . The results of non-clinical testing support that these minor differences do not raise any new questions of safety and effectiveness.
It is concluded that the Chang Gung "ComMed" Series Dental Implant System is substantially equivalent to the predicate and reference devices.
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4.6 Non-clinical Testing
Performance testing was conducted to support the substantial equivalence of the subject device. This testing included Static and Dynamic fatigue loading, Biocompatibility, Packaging Shelf Life Validation and Sterilization Validation (Table 1).
| Device | Test | Relevantstandard | |
|---|---|---|---|
| Biocompatibility | Implant | In vitro cytotoxicity study | ISO 10993-5 |
| Intracutaneous reactivity study | ISO 10993-10 | ||
| Skin sensitization study | ISO 10993-10 | ||
| Acute systemic toxicity | ISO 10993-11 | ||
| Pyrogenicity study | ISO 10993-11 | ||
| 14-day repeated dose systemic toxicitystudy | ISO 10993-11 | ||
| In vitro haemolysis study | ISO 10993-4 | ||
| In vitro bacterial reverse mutation (AMES)study | ISO 10993-3 | ||
| In vitro chromosome aberration study | ISO 10993-3 | Abutment | |
| In vitro mammalian cell gene mutationstudy | ISO 10993-3 | ||
| Bone formation and histological study | ISO 10993-6 | ||
| Abutment | In vitro cytotoxicity study | ISO 10993-5 | |
| Intracutaneous reactivity study | ISO 10993-10 | ||
| Skin sensitization study | ISO 10993-10 |
Table 1. Tests and relevant standards
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| Static and dynamicfatigue loading | |||
|---|---|---|---|
| Implantandstandardabutment | Static and dynamic fatigue test | ISO 14801 | |
| Implantand angleabutment | Static and dynamic fatigue test | ISO 14801 | |
| Sterilization validation | Implant | Sterilization validation of Gammairradiation | ISO 11737-1ISO 11737-2 |
| Abutment | Moist heat validation- microbiologicalperformance qualification | ISO 11737-1ISO 11737-2ISO 17665-1 | |
| Packaging shelf life validation | Implant | Burst and creep tests | ASTM F1140 |
| Dye penetration test | ASTM F1929 | ||
| Seal peel test | ASTM F88/F88M | ||
| Microbial ranking test | ASTM F1608 | ||
| Burst, creep, dye penetration, seal peel,and microbial ranking tests after 2 yearsaccelerated aging | ASTM F1980ASTM F1140ASTM F1929ASTM F88/F88MASTM F1608 | ||
| Burst, creep, dye penetration, seal peel,and microbial ranking tests after 3 yearsaccelerated aging | ASTM F1980ASTM F1140ASTM F1929ASTM F88/F88MASTM F1608 | ||
| Burst, creep, dye penetration, seal peel,and microbial ranking tests after 5 yearsaccelerated aging | ASTM F1980ASTM F1140ASTM F1929ASTM F88/F88MASTM F1608 |
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4.7 Conclusion
This submission is seeking marketing clearance for the Chang Gung "ComMed" Series Dental Implant System which includes threaded root-form endosseous dental implants as well as dental implant abutments. These devices have been evaluated using non-clinical performance and bench testing. This testing included static and dynamic mechanical loading, biocompatibility testing, sterilization validation, and packaging life validation. The technological characteristics of this device system do not raise different questions of safety and effectiveness. The information included in this submission supports the substantial equivalence of the Chang Gung "ComMed" Series Dental Implant System to the identified predicate and reference devices for its intended use.
§ 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.