(249 days)
Royal-Dent Eureka 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. Royal-Dent Eureka Dental Implant System is for one and two stage surgical procedures. It's not for immediate load.
Royal-Dent Eureka Dental Implant System is a multiple component device, made from CP Ti and Ti-6Al-4V, which allow the surgeon to build an implant system to fit the patient's requirements. The system is a set of implants designed to be inserted into the upper and/or lower jawbone and serves as a replacement for patient's tooth providing a stable foundation for restorations. The system is provided with simplified main implants, but with a variety of different styles of components. Eureka and Eureka Plus implant series are the sub-types incorporated into Royal-Dent Dental Implant System. The major difference between two implant sub-types is outer design configuration. The design configuration and features of inner hole for the sake of fitness to various screws and abutments are identical. The Implants are provided sterile, the remaining components must be sterilized prior to use.
The provided text describes the 510(k) summary for the "Royal-Dent Eureka Dental Implant System." This document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than a clinical study evaluating AI performance. Therefore, many of the requested criteria related to AI device performance evaluation, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or cannot be extracted from this specific document.
The document primarily details the device's characteristics, intended use, and pre-clinical bench and biocompatibility testing to show similarity to existing approved devices.
Here's an analysis of the provided information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the format of quantitative thresholds for performance metrics. Instead, "acceptance" is demonstrated through substantial equivalence to predicate devices and adherence to relevant ISO standards for bench and biocompatibility testing. The "reported device performance" is essentially that the device performed acceptably in these pre-clinical tests, supporting its safety and effectiveness.
| Criteria Category | Details Provided in Submission |
|---|---|
| Substantial Equivalence to Predicate Devices | Indication for Use: "Royal-Dent Eureka 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. Royal-Dent Eureka Dental Implant System is for one and two stage surgical procedures. It's not for immediate load." (Identical or very similar to predicate devices, noting the subject device allows for one and two-stage procedures while predicates were for one-stage).Materials: "CP Ti : dental implant"; "Ti6Al4V: abutments, screws, healing caps, clix." (Similar to predicate devices which also use CP Ti and Ti6Al4V, though predicates also list Gold alloy + plastic for some components).Use: "Single use" (Same as predicate devices).Dimensions: Diameter: 3.5, 4.0, 4.3, 4.5, 5.0mm; Length: 8.5, 10,11.5,13,15mm (Similar to predicate devices, which have a slightly wider length range starting from 7.0mm).Method of Sterilization: "Gamma sterilization: implant; Abutments and accessories : non-sterile" (Same as predicate devices).Conclusion: "Based on the similarities between the Royal-Dent Eureka Dental Implant System and the predicate devices, the safety and effectiveness of the Royal-Dent Eureka Dental Implant System is substantially equivalent to the predicate devices." |
| Pre-clinical Testing Results | Bench testing: Per ISO 14801 (Implied successful passing of this static and dynamic fatigue strength test for endosseous dental implants).Biocompatibility Testing:- Genotoxicity Testing per ISO 10993-3 (Implied acceptable results).- Cytotoxicity testing per ISO 10993-5 (Implied acceptable results).- Implantation testing per ISO 10993-6 (Implied acceptable results).- Sensitization testing per ISO10993-10 (Implied acceptable results).- System Injection testing per ISO10993-11 (Implied acceptable results).Conclusion: "Performance Testing were also conducted to demonstrate safety and effectiveness of the proposed devices." (This statement implies the tests met the required standards for safety and effectiveness). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this document describes the 510(k) clearance process for a dental implant system, not a study involving a "test set" for an AI device. The testing mentioned (bench and biocompatibility) refers to a mechanical and biological evaluation of the implant material and design, not an AI algorithm's performance on a dataset.
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)
This information is not applicable. There is no "ground truth" for a "test set" in the context of an AI device being evaluated. The evaluations were based on established ISO standards for material and mechanical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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
This information is not applicable. This document is for a dental implant, not an AI device, so no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The "ground truth" in this context refers to established scientific and engineering principles, and validated test methodologies defined by ISO standards for evaluating the physical and biological properties of medical devices.
8. The sample size for the training set
This information is not applicable as this is not an AI device.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI device.
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510(k) Summary (K122804)
The summary of 510(k) safety and effectiveness information is being submitted in accordance with requirement of 21 CFR Part 807.92
| Date : | May 20, 2013 |
|---|---|
| Submitter : : | INTAI TECHNOLOGY CORP. |
| Address : | No.9, Jingke Rd., Nantun Dist .Taichung City,TaiwanTel : 886-4-3601-5336Fax: 886-4-3601-9772 |
| Contact Person : | Kevin Wang, Regulatory Affairs Specialist |
| Trade Name : | Royal-Dent Eureka Dental Implant System |
| Device Classification : | Class II |
| Classification Name : | Endosseous dental implant, Endosseous dental implant abutment |
| Regulation Number : | 872.3640, 872.3630 |
| Product Code : | DZE, NHA |
| Predicate Devices : | GS System (K063861)GS III System (K091208) |
| Device Description : | Royal-Dent Eureka Dental Implant System is a multiple component device,made from CP Ti and Ti-6Al-4V, which allow the surgeon to build animplant system to fit the patient's requirements. The system is a set ofimplants designed to be inserted into the upper and/or lower jawbone andserves as a replacement for patient's tooth providing a stable foundationfor restorations. The system is provided with simplified main implants, butwith a variety of different styles of components. Eureka and Eureka Plusimplant series are the sub-types incorporated into Royal-Dent DentalImplant System. The major difference between two implant sub-types isouter design configuration. The design configuration and features of innerhole for the sake of fitness to various screws and abutments are identical.The Implants are provided sterile, the remaining components must besterilized prior to use. The size information is as below. |
| Eureka Implant |
|---|
| Dia. 3.5mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |
| Dia. 4.0mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |
| Dia. 4.5mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |
| Dia. 5.0mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |
| Eureka Plus Implant |
|---|
| Dia. 3.5mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |
| Dia. 4.3mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |
| Dia. 5.0mm x (L) 8.5mm, 10mm, 11.5mm, 13mm, 15mm. |
| Abutments |
|---|
| ----------- |
: 3.5mm6mm Diameter Vertical High : 2.5mm10mm
.
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Indication for Use :
Royal-Dent Eureka 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.
Royal-Dent Eureka Dental Implant System is for one and two stage surgical procedures. It's not for immediate load.
Technological Characteristics :
| Subject Device | Predicate Devices | |
|---|---|---|
| Device | GS System (K063861) | |
| Name | Royal-Dent Eureka Dental Implant System | GS III System (K091208) |
| Indicationfor use | Royal-Dent Eureka Dental Implant System isindicated for use in partially or fully edentulousmandibles and maxillae, in support of single ormultiple-unit restorations including: cementedretained, screw retained or overdenturerestorations, and terminal or intermediate abutmentsupport for fixed bridgework. Royal-Dent EurekaDental Implant System is for one and two stagesurgical procedures. It's not for immediate load. | GS System and GS III System are indicated for usein partially or fully edentulous mandibles andmaxillae, in support of single or multiple-unitrestorations including: cemented retained, screwretained or overdenture restorations, abutmentssupport for fixed bridgework. GS and GS III Systemis for one stage surgical procedures. It's not forimmediate load. |
| CP Ti : dental implant | CP Ti: dental implant, cover screw, healing abutment. | |
| Material(s) | Ti6Al4V: abutments, screws, healing caps, clix. | Ti6Al4V: abutments, screws, healing caps, clix.Gold alloy + plastic: casting abutment, cylinder. |
| Use | Single use | Single use |
| Dimensionof Implants | Diameter: 3.5, 4.0, 4.3, 4.5, 5.0mmLength: 8.5, 10,11.5,13,15mm | Diameter: 3.5, 4.0,4.3, 4.5, 5.0mmLength: 7.0,8.5,10,11.5,13,15mm |
| Method ofsterilization | Gamma sterilization: implantAbutments and accessories : non-sterile | Gamma sterilization: implantAbutments and accessories : non-sterile |
Performance Data :
Pre-clinical testing of Royal-Dent Eureka Dental Implant System
- ♦ Bench testing per ISO 14801
- Genotoxicity Testing per ISO 10993-3
- Cytotoxicity testing per ISO 10993-5
- Implantation testing per ISO 10993-6
- Sensitization testing per ISO10993-10
- System Injection testing per ISO10993-11
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Conclusion :
The comparisons of Royal-Dent Eureka Dental Implant System and predicate devices show that the devices are manufactured from same or similar materials, and have the same indication for use and similar design characteristics. Performance Testing were also conducted to demonstrate safety and effectiveness of the proposed devices. Based on the similarities between the Royal-Dent Eureka Dental Implant System and the predicate devices, the safety and effectiveness of the Royal-Dent Eureka Dental Implant System is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a person embracing another person.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2013
Mr. Kevin Wang Regulatory Affairs Specialist INTAI Technology Corporation No.9, Jingke Road, Nantun District Taichung City, Taiwan 40852
Re: K122804
Trade/Device Name: Royal-Dent Eureka Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 16, 2013 Received: May 16, 2013
Dear Mr. Wang:
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/8 description: The image shows the name "Kwame O. Ulmer-S" in a bold, sans-serif font. The text is arranged in two lines, with "Kwame O." on the top line and "Ulmer-S" on the bottom line. There is a design to the right of the name that looks like a triangle.
for
Anthony D. Watson, B.S., M.S., M.B.A. 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): K122804 Device Name: Royal-Dent Eureka Dental Implant System Indications for Use:
Royal-Dent Eureka 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.
Royal-Dent Eureka Dental Implant System is for one and two stage surgical procedures. It's not for immediate load.
| Prescription Use(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) | |
|---|---|---|---|---|
| ------------------------------------------------- | --- | -- | -------- | ------------------------------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Digitally signed by Mary S. Runner -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Mary S. Runner
0.9.2342.19200300.100.1.1=1300087950
Date: 2013.05.20 12:09:36 -04'00'
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K122804 |
|---|---|
| ---------------- | --------- |
4-1
510(k) Number._
§ 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.