(264 days)
No
The description focuses on the physical characteristics, materials, and mechanical performance of the dental implant system. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as "intended for surgical placement in the maxilla or mandible to provide for prosthetic attachment to restore a patient's chewing function," which clearly indicates a therapeutic purpose.
No
The device is a dental implant system used for surgical placement to restore chewing function, not for diagnosing conditions.
No
The device description clearly outlines physical components made of titanium and Ti6Al4V, which are hardware. The performance studies also focus on physical properties like fatigue loading and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for surgical placement in the maxilla or mandible to provide for prosthetic attachment and restore chewing function. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device is described as dental implants and abutments, which are physical components implanted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a medical implant.
N/A
Intended Use / Indications for Use
"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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Chang Gung "ComMed" Series Dental Implant System consists of a dental implant (fixture), healing abutment, standard abutment, and angle abutment. The implant is a cylindrical and tapered post that serves as a substitute for the tooth root. The system also includes accessories such as a cover screw, mount, and mount screw. The implants are made of Grade 4 Pure Titanium, and the abutments are made of Ti6Al4V. The implants have an internal hex with Morse Taper 8° connection, platform switching, and fine thread in the neck. They are available in diameters of 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm and lengths of 10, 11, 12, 13, 14, 15, 16 mm. Angle abutments (15°) are also available. The surface treatment involves blasting with Aluminum Oxide and Acid Etching, and Anodized Treatment. Implants are sterilized by Gamma irradiation, and abutments require moist heat sterilization before use by clinicians.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
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)
Performance testing included Static and Dynamic fatigue loading, Biocompatibility, Packaging Shelf Life Validation and Sterilization Validation.
Biocompatibility tests included: 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, and Bone formation and histological study.
Static and dynamic fatigue loading tests were performed on the implant and standard abutment, and implant and angle abutment.
Sterilization validation was performed for Gamma irradiation for implants and moist heat validation for abutments.
Packaging shelf life validation included Burst and creep tests, Dye penetration test, Seal peel test, and Microbial ranking test, after 2, 3, and 5 years of accelerated aging.
The results of non-clinical testing support that minor differences in design features between the subject and predicate/reference devices do not raise any new questions of safety and effectiveness.
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.
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
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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.
1
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
2
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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3
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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" Series |
| Dental 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
4
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 10508 | |
| Factory: Chang Gung Medical Technology Co., Ltd. Linkou | |
| Factory | |
| 2F., No. 118, Nanlin Rd., Taishan Dist., New Taipei | |
| City 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 |
5
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 intended |
| for surgical placement in the maxilla or mandible to | |
| provide means for prosthetic attachment to restore a | |
| patient' s chewing function. "ComMed" Series Dental | |
| Implants are intended only for delayed loading. | |
| Material | Implant: Grade 4 Pure Titanium |
| Abutment: 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 irradiation |
| Abutment : Moist heat sterilization before use by | |
| clinicians. |
6
Components
| Name | Function | Accessories |
|---|---|---|
| Standard Implant | ||
| (Fixture) | A cylindrical and tapered post that | |
| serves as a substitute for the tooth root. | Cover Screw | |
| Mount | ||
| Mount Screw | ||
| Healing Abutment | Attached to the fixture for gingival | |
| forming. | N/A | |
| Standard Abutment | A connector built into the top of the | |
| fixture to straightly attach the implant to | ||
| the replacement tooth. | Abutment Screw | |
| Angle Abutment | A connector built into the top of the | |
| fixture to obliquely attach the implant to | ||
| the replacement tooth. | Abutment Screw | |
| Accessories | ||
| Cover Screw | A screw placed on the superior part of a | |
| fixture during osseointegration period. | ||
| The Cover Screw size depends on the | ||
| corresponding Standard Implant. | N/A | |
| Mount | A temporary part to connect fixture to | |
| driver for placement. The Mount size | ||
| depends on the corresponding Standard | ||
| Implant. | N/A | |
| Mount Screw | Connection implant with mount. The | |
| Mount Screw size depends on the | ||
| corresponding Standard Implant. | N/A | |
| Abutment Screw | Connection implant with standard | |
| abutment or angle abutment. The | ||
| Abutment Screw size depends on the | ||
| corresponding Abutment. | N/A |
7
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 |
8
- Healing Abutment : .
| Model Type | Model No. | Specification | Model Type | Model No. | Specification |
|---|---|---|---|---|---|
| Healing | |||||
| Abutment | UTAB3501 | Ø 3.5mm / GH 1 | Healing | ||
| Abutment | 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 |
9
- Standard Abutment : .
| Model Type | Model No. | Specification | Model Type | Model No. | Specification |
|---|---|---|---|---|---|
| Standard | |||||
| Abutment | UTBA3501 | Ø 3.5mm / GH 1 | Standard | ||
| Abutment | 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 |
10
●
| 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 |
11
| | Subject Device | Predicate device | Reference device
#1 | Reference device
#2 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | - | K033984 | K073075 | K040807 |
| Indication for
use | "ComMed" Series
Dental Implant
System is
intended for
surgical
placement in the
maxilla or
mandible to
provide means for
prosthetic
attachment to
restore a
patient's
chewing function.
"ComMed" Series
Dental Implants
are intended only
for delayed
loading. | The ITI Dental
System implants
are for
single-stage or
two-stage surgical
procedures. The
implants are
intended for
immediate
placement and
function on
single-tooth
and/or multiple
tooth applications
when good
primary stability is
achieved and with
appropriate
occlusal loading,
to restore chewing
function. Multiple
tooth applications
may be rigidly
splinted. In the
case of
edentulous
patients, 4 or
more implants
must be used in
immediately | The FRIADENT
Implant systems
are for
single-stage or
two-stage surgical
procedures and
cemented or
screw retained
restorations. The
FRIADENT Implant
Systems are
intended for
immediate
placement and
function on single
tooth and/or
multiple tooth
applications when
good primary
stability is
achieved, with
appropriate
occlusal loading,
in order to restore
chewing function.
Multiple tooth
applications may
be splinted with a
bar. | The MIS Dental
Implant System is
indicated for use
in surgical and
restorative
applications for
placement in the
bone of the upper
or lower jaw to
provide support
for prosthetic
devices, such as
artificial teeth, in
order to restore
the patient's
chewing function. |
| | | loaded cases. | | |
| Trade name | Chang Gung
"ComMed " Seri
es Dental Implant
System | STRAUMANN
DENTAL IMPLANT
SYSTEM | FRIADENT Implant MIS DENTAL
Systems - XiVE® S
Plus Dental
Implant System | IMPLANT SYSTEM |
| Material | Implant: Grade 4
Pure Titanium
Abutment:
Ti-6Al-4V | Implant: Grade 4
Pure Titanium
Abutment: Grade
4 Pure Titanium | Implant: Grade 2
Pure Titanium
Abutment:
Ti-6Al-4V / Grade
2 Pure Titanium | Implant: Grade 4
Pure Titanium
Abutment:
Ti-6Al-4V |
| Connection
type | Internal hex with
Morse taper 8° | Internal hex with
Morse taper | Internal hex | Internal hex with
Morse taper,
internal octa with
Morse taper |
| Platform
switching | Yes | Yes | No | No |
| Micro-thread
at implant
neck | Yes | No | No | Yes |
| Diameter
(mm) | 3.5, 4.0, 4.5, 5.0,
5.5, 6.0 | 3.34.8 | 3.05.5 | 3.36.0 |14 | 8
| Length (mm) | 10, 11, 12, 13, 14,
15, 16 | 818 | 616 |
| Angle
abutment | Yes (15°) | Yes (15°) | Yes (15°) | Yes (15°) |
| Surface
modification | Blasted with
aluminum oxide
and acid etched | Blasted with
aluminum oxide
and acid etched | Blasted with
aluminum oxide
and acid etched | Blasted with
aluminum oxide
and acid etched |
| Anodizing | Yes | Yes | Yes | Yes |
| Sterilization
method | Gamma
irradiation | Gamma
irradiation | Gamma
irradiation | Gamma
irradiation |
4.4 Predicate and Reference Devices
12
13
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.
14
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 | Relevant
standard |
|------------------|------------------------------------------------|-----------------------------------------------------|----------------------|
| 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 toxicity
study | 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 mutation
study | 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
15
| Static and dynamic
| fatigue loading | |||
|---|---|---|---|
| Implant | |||
| and | |||
| standard | |||
| abutment | Static and dynamic fatigue test | ISO 14801 | |
| Implant | |||
| and angle | |||
| abutment | Static and dynamic fatigue test | ISO 14801 | |
| Sterilization validation | Implant | Sterilization validation of Gamma | |
| irradiation | ISO 11737-1 | ||
| ISO 11737-2 | |||
| Abutment | Moist heat validation- microbiological | ||
| performance qualification | ISO 11737-1 | ||
| ISO 11737-2 | |||
| ISO 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 years | |||
| accelerated aging | ASTM F1980 | ||
| ASTM F1140 | |||
| ASTM F1929 | |||
| ASTM F88/F88M | |||
| ASTM F1608 | |||
| Burst, creep, dye penetration, seal peel, | |||
| and microbial ranking tests after 3 years | |||
| accelerated aging | ASTM F1980 | ||
| ASTM F1140 | |||
| ASTM F1929 | |||
| ASTM F88/F88M | |||
| ASTM F1608 | |||
| Burst, creep, dye penetration, seal peel, | |||
| and microbial ranking tests after 5 years | |||
| accelerated aging | ASTM F1980 | ||
| ASTM F1140 | |||
| ASTM F1929 | |||
| ASTM F88/F88M | |||
| ASTM F1608 |
16
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.