(80 days)
The EZ Plus Implant Systems are intended to be surgically placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. Large angle abutments (e.g. 25°) on small diameter implants of the EZ Plus internal connection system are intended for the anterior region of the mouth and not intended for use in the posterior region of the mouth due to limited strength of the implant.
The EZ Plus Implant system consists of machined titanium, screw-form, root-form endosseous dental implant. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw (for UCLA abutments) and cement (for solid abutments) retained restoration for multi-mount options. Fixtures, the prosthetics, and the surgical instruments are produced and packaged separately. All included devices in the system are covered by this submission.
This submission describes the EZ Plus Implant System, an endosseous dental implant. The document is a 510(k) summary for premarket notification, indicating a pathway for market clearance based on substantial equivalence to a predicate device, rather than a de novo approval requiring extensive clinical efficacy studies with predefined acceptance criteria.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this type of regulatory submission.
The 510(k) submission primarily focuses on demonstrating that the new device (EZ Plus Implant System) is as safe and effective as a legally marketed predicate device (EXFEEL IMPLANT SYSTEM). This is typically achieved through comparative data on design, materials, sterilization, indications for use, and mechanical testing, rather than clinical performance metrics relative to predefined acceptance criteria in the context of device performance.
Here's the relevant information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. The submission does not define specific clinical acceptance criteria for performance metrics (e.g., success rates, failure rates) for the EZ Plus Implant System. Its clearance is based on substantial equivalence to a predicate device.
Instead, the submission includes a comparative table to demonstrate equivalence:
| Content | Subject Device (EZ Plus Implant System) | Predicate Device (ExFeel Implant System) |
|---|---|---|
| 510(K) Number | Not available yet | K052369 |
| Characteristic | EZ Plus Implant System | ExFeel Implant System |
| Manufacturer | MegaGen Co., Ltd. | MegaGen Co., Ltd. |
| Indications for Use | Mandible and Maxilla Endosseous Dental Implant & Accessories | Mandible and Maxilla Endosseous Dental Implant & Accessories |
| Design: | Internal and External Hex | Internal and External Hex |
| Endosseous Implant Material | Commercial pure titanium | Commercial pure titanium |
| Implant Sterile | Yes | Yes |
| Sterilization Method | Gamma | Gamma |
| Implant Diameters | - Internal Type Implant: 3.3, 4.0, 5.0mm - External Type Implant: 3.3, 4.0, 5.0mm | 3.5, 4.1, 4.8mm (Internal) 3.30, 3.75, 4.0, 5.0mm (External) |
| Implant Lengths | - Internal Type Implant: 8.0, 10.0, 11.0, 13.0, 15.0, 18.0mm - External Type Implant: 8.0, 10.0, 11.0, 13.0, 15.0, 18.0mm | - Internal Type Implant: 7.0, 8.5, 10.0, 11.5, 13.0mm - External Type Implant: 8.5, 10.0, 11.5, 13.0, 15.0, 18.0mm |
| Attachments | Various abutments and components | Various abutments and components |
| Product Code | DZE | DZE |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a 510(k) submission, not a clinical trial report with a defined test set of patient data for performance evaluation. The "test" mentioned refers to laboratory testing for functionality and conformance to design requirements, not clinical data.
The document states, "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." No details regarding the sample size or provenance of data from this laboratory testing are provided in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth for clinical performance is not established or discussed in this 510(k) summary as it is not a clinical efficacy study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 physical dental implant, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical dental implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. Ground truth in the context of clinical outcomes or diagnostic accuracy is not established or discussed. The "ground truth" here would be adherence to engineering specifications and performance in mechanical tests.
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" in the context of this device's regulatory submission.
9. How the ground truth for the training set was established:
Not applicable.
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13. 510(K) SUMMARY
MAY 1 8 2007
Mega'Gen Co., Ltd. 114-8, Eupchun-Ri, Jain-Myun, Gyeongsan, Gyeongbuk South Korea Phone: 82-53-857-5770, Fax: 82-53-857-5432
510(K) Summary
510(K) SUMMARY AND CERTIFICATION This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR & 807.93
- 13-1. Submitter Mega'Gen Co., Ltd. 114-8, Eupchun-Ri, Jain-Myun, Gyeongsan, Gyeongbuk South Korea Phone: 82-53-857-5770, Fax: 82-53-857-5432 13-2. US Agent / Dae Kyu Chang Contact Person 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Phone : 562-404-8466, Fax : 562-404-2757 13-3. Date Prepared May 1, 2007 EZ PLUS ® IMPLANT SYSTEMS 13-4. Device Name 13-5. Classification Name Endosseous Dental Implant System 13-6. Device Classification Class II Dental Devices panel 21 CFR & 872.3640 Regulation Number: 872.3640 13-7. Predicate Devices EXFEEL IMPLANT SYSTEM(K052369) 13-8. Performance Laboratory testing was conducted to determine device functionality and conformance to design input requirements.
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13-9. Device Description
The EZ Plus Implant system consists of machined titanium, screw-form, root-form endosseous dental implant. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw (for UCLA abutments) and cement (for solid abutments) retained restoration for multi-mount options. Fixtures, the prosthetics, and the surgical instruments are produced and packaged separately. All included devices in the system are covered by this submission.
13-10. Packing / Labeling / Product Information
In a clean room that is Class 10,000 or less, put the product into a capsule, and then put the capsule in a pet container, which is 45mm by 75mm, then sealed the pet container with PERFECSEAL CR27 1073B Coated Tyvek®. EZ PLUS™ Implant Systems (EZ Plus™ Implant Fixtures, EZ Plus Protective Cap and EZ Plus Implant system surgery tray) will be packed.
13-11. Intended Use
The EZ Plus Implant Systems are intended to be surgically placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. Large angle abutments (e.g. 25°) on small diameter implants of the EZ Plus internal connection system are intended for the anterior region of the mouth and not intended for use in the posterior region of the mouth due to limited strength of the implant.
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13-12. Substantial Equivalence Comparison
13-12-1. Comparative data
| Content | Subject Device | Precedent Device |
|---|---|---|
| 510(K) Number | Not available yet | K052369 |
| Characteristic | EZ Plus Implant System | ExFeel Implant System |
| Manufacturer | MegaGen Co., Ltd. | MegaGen Co., Ltd. |
| Indications for Use | Mandible and Maxilla Endosseous Dental Implant &Accessories | Mandible and Maxilla Endosseous DentalImplant & Accessories |
| Design: | Internal and External Hex | Internal and External Hex |
| EndosseousImplant Material | Commercial pure titanium | Commercial pure titanium |
| Implant Sterile | Yes | Yes |
| SterilizationMethod | Gamma | Gamma |
| Implant Diameters | - Internal Type Implant: 3.3,4.0, 5.0mm- External Type Implant 3.3, 4.0, 5.0mm | 3.5, 4.1, 4.8mm(Internal)3.30, 3.75, 4.0, 5.0mm(External) |
| Implant Lengths | -Internal Type Implant : 8.0, 10.0,11.0, 13.0,15.0,18.0mm- External Type Implant : 8.0,10.0, 11.0, 13.0, 15.0,18.0mm | - Internal Type Implant: 7.0, 8.5, 10.0, 11.5,3.0mm- External Type Implant:8.5, 10.0, 11.5, 13.0,15.0, 18.0mm |
| Attachments | Various abutments and components | Various abutments and components |
| Product Code | DZE | DZE |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, emphasizing the department's role within the United States.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2007
Mega'Gen Company, Limited C/O Mr. Dae Kyu Chang Kodent Incorporation 13340 E. Firestone Boulevard, Suite J Santa Fe Springs, California 90670
Re: K070562
Trade/Device Name: EZ Plus Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: NHA Dated: May 1, 2007 Received: May 4, 2007
Dear Mr. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Chang
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Senite Y. Michael Omd.
Chiu Lin, Ph.D. 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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Indication for Use
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: EZ Plus Implant System
Indications For Use:
The EZ Plus Implant Systems are intended to be surgically placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. Large angle abutments (e.g. 25°) on small diameter implants of the EZ Plus internal connection system are intended for the anterior region of the mouth and not intended for use in the posterior region of the mouth due to limited strength of the implant.
| Prescription Use _(Part 21 CFR 801 Subpart D) | OR |
|---|---|
| Over-The-Counter Use(Per 21 CFR 801.109) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Susan Rumsey
Concurrence of
: 2(k) Number: RO 105
Page 1 of 1
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)