(277 days)
The DIO UF HSA Internal Sub-Merged Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller (03.8 ~ (05.5) implants can be placed with a conventional two stage surgival process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading. The larger (Ø6.0 ~ Ø7.0) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.
The DIO UF HSA Internal Sub-Merged Implant System is comprised of dental implants, superstructures, instruments for prosthetics and surgical instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The DIO UF HSA Internal Sub-Merged Implant System, fixtures are made of pure titanium, grade 4(ASTM F67) which have a a S.L.A commercial (Sand-blasted Large grit Acid-etched) treated surface. These fixtures can be used one-stage surgery method or two-stage surgery method. And that are surgically inserted into the upper and/or lower jaw bone. The fixtures replace tooth root as providing a stable foundation for restorations. The fixtures have the diameter(3.8 ~ 7.0mm)and length.(7 ~ 16mm). Geometrically, the implant is screw-type. An abutment is connected to the implant through a tapered-joint. The device functions by being surgically implanted in the bone of the upper or lower iaw arches in order to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function.
Acceptance Criteria and Study Details for DIO UF HSA Internal Sub-Merged Implant System
This submission pertains to the DIO UF HSA Internal Sub-Merged Implant System, which is a dental implant device. The provided document details a 510(k) submission, indicating a focus on demonstrating substantial equivalence to a legally marketed predicate device rather than outright safety and effectiveness from de novo studies.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for this device is substantial equivalence to its predicate device, Implantium II (K060501). This is primarily assessed through non-clinical performance testing (fatigue testing) and comparison of material, design, intended use, and other characteristics.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical Fatigue Limit | Must be over 250N with no fracture, cracks, or severe distortion of any parts after 5x10⁶ cycles at 14Hz frequency and 35° tilting angle (matching predicate device). A "worst case scenario" of the DIO HSA STEADY Internal Sub-Merged Fixture and an angled abutment was tested. |
| Material Composition | CP Ti Gr4 (ASTM F67) for fixtures, CP Ti Gr3, Gr4 (ASTM F67) & Ti Alloy (ASTM F136:Ti-6Al-4V ELI) for abutment. |
| Design Characteristics | Internal Type and Morse Tapered screw-type implant. |
| Implant Diameters | 3.8 ~ 7.0 mm |
| Implant Lengths | 7 ~ 16 mm |
| Surface Treatment | S.L.A (Sand-blasted Large grit Acid-etched) for implant fixture. Machined type for abutment surface. |
| Sterilization Method | Gamma for implant fixture. Non-sterilization for abutment. |
| Intended Use | Surgical placement in upper/lower jaw arches to provide root form for single/multiple prosthetic units to restore chewing function. Smaller implants (Ø3.8 ~ Ø5.5) for conventional two-stage or single-stage immediate loading. Larger implants (Ø6.0 ~ Ø7.0) for conventional two-stage in molar region with delayed loading. |
Reported Performance: The document explicitly states, "The fatigue limit is over 250N (Fracture or cracks or severe distortion of any parts were not detected.). It is the same fatigue limit of predicate device." It also claims that "The DIO UF HSA Internal Sub-Merged Implant System has same material and characteristics as design and technological the indication for used, similar predicate device." and "There are no known technological differences between the DIO UF HSA Internal Sub-Merged Implant System and Implantium II." This indicates that the device met the stated acceptance criteria for substantial equivalence to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The primary test set mentioned is for fatigue testing.
- Sample Size: Not explicitly stated as a number of devices/implants tested, but implies that "the worst case scenario of the DIO HSA STEADY Internal Sub-Merged Fixture and an angled abutment" was tested. This suggests a representative sample of configurations were subjected to the specified fatigue conditions.
- Data Provenance: The testing was conducted by the manufacturer, DIO Corporation, in Korea, as indicated by the submitter information. The data is thus prospective, generated specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This submission does not involve clinical studies with human subjects or image-based diagnostics requiring expert interpretation for ground truth. The "ground truth" for the non-clinical fatigue testing is the physical failure analysis of the tested devices against predefined engineering criteria (e.g., absence of fracture, cracks, or severe distortion, and exceeding the 250N fatigue limit). This evaluation would typically be performed by qualified engineers or technicians in a laboratory setting, rather than clinical experts. The number and qualifications of such individuals are not specified in this document.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical, objective assessment of mechanical properties (fatigue testing), not a subjective clinical or diagnostic evaluation requiring an adjudication process for varying expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is a dental implant, and the submission is a 510(k) for substantial equivalence, primarily relying on non-clinical testing and comparison to a predicate device, not on assessing human reader performance or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study (in the context of an algorithm's performance) was not done. This device is a physical medical device (dental implant), not an AI algorithm or software. Therefore, the concept of algorithm-only performance is not applicable.
7. Type of Ground Truth Used
The ground truth for the non-clinical fatigue testing was engineering data/physical failure analysis. This includes objective measurements of load endured, number of cycles, and visual/microscopic inspection for material integrity (absence of fracture, cracks, severe distortion).
8. Sample Size for the Training Set
Not applicable. This submission is for a physical medical device (dental implant), not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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MAY 2 1 2013
Traditional 510(k) Submission
DIO UF HSA Internal Sub-Merged_Implant System
Attachment 4
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
Preparation date : Feb 15, 2013
| 1. Submitter | DIO Corporation | |
|---|---|---|
| 66, Centumseo-ro, Haeundae-gu, Busan, Korea | ||
| Tel.: 82-51-745-7777 | Fax.: 82-51-745-7778 | |
| 2. US Agent /Contact Person | DIO, USA Tim C.J. Lee | |
| 3540 Wilshire Blvd. #1104 Los Angeles, CA 90010, USA | ||
| Tel.: 213-365-2875 | Fax.: 213-365-1595 | |
| 3. Trade Name | DIO UF HSA Internal Sub-Merged Implant System | |
| 4. Common Name | Dental Implant | |
| 5. Classification Name | Endosseous Dental Implant | |
| 21 CFR 872.3640 | ||
| ClassII DZE, NHA | ||
| Endosseous Dental implant abutment | ||
| 21 CFR 872.3640 | ||
| ClassII DZE. NHA | ||
| 6. Predicate Devices | Implantium II (510(k) No: K060501) |
7. Device Description
The DIO UF HSA Internal Sub-Merged Implant System is comprised of dental implants, superstructures, instruments for prosthetics and surgical instruments.
The DIO UF HSA Internal Sub-Merged Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a
{1}------------------------------------------------
firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
The DIO UF HSA Internal Sub-Merged Implant System, fixtures are made of pure titanium, grade 4(ASTM F67) which have a a S.L.A commercial (Sand-blasted Large grit Acid-etched) treated surface. These fixtures can be used one-stage surgery method or two-stage surgery method. And that are surgically inserted into the upper and/or lower jaw bone. The fixtures replace tooth root as providing a stable foundation for restorations. The fixtures have the diameter(3.8 ~ 7.0mm)and length.(7 ~ 16mm)
Geometrically, the implant is screw-type. An abutment is connected to the implant through a tapered-joint.
The device functions by being surgically implanted in the bone of the upper or lower iaw arches in order to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function.
With regard to the scientific concepts that form the basis for the device, root-form endosseous dental implant devices are characterized by four geometrically distinct types. The DIO UF HSA Internal Sub-Merged Implant System is a screw endosseous dental implant. With regard to the physical and performance characteristics of The DIO UF HSA Internal Sub-Merged Implant System, the design shape, engaging method, implant surface treatment and dimensions (lengths and diameters) are the same as the lawfully marketed predicate device.
Test performed in air at 24℃. at 14Hz frequency for at least 5×106 cycles. Tilting angles of specimen is 35°. The fatigue limit is over 250N (Fracture or cracks or severe distortion of any parts were not detected.). It is the same fatigue limit of predicate device.
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Substantial Equivalence Comparison
There are no known technological differences between the DIO UF HSA Internal Sub-Merged Implant System and Implantium II.
| Subject Device | Predicate Device | |
|---|---|---|
| ManufacturerName | DIO Corporation | Dentium Co., Ltd. |
| Device Name | DIO UF HSA InternalSub-Merged Implant System | Implantium II |
| Intended Use | The DIO UF HSA Internal Sub-MergedImplant System is indicated for surgicalplacement in the upper and lower jawarches, to provide a root form means forsingle or multiple units' prostheticattachment to restore a patient's chewingfunction. Implants can be placed with aconventional two stage surgical processwith an option for transmucosal healingor they can be placed in a single stagesurgical process for immediate loading. | Implantium II is intended to besurgically placed in the bone of theupper or lower jaw arches toprovide support for prostheticsdevices, such as artificial teeth, andto restore the patient's chewingfunction. |
| Fixture Material | CP Ti Gr4 (ASTM F67) | CP Ti Gr4 (ASTM F67) |
| Design | Internal Type and Morse Tapered | Internal Type and Morse Tapered |
| Implant | ||
| Diameters(mm) | 3.8 ~ 7.0 | 3.6 ~ 5.0 |
| Implant | ||
| Lengths(mm) | 7 ~ 16 | 8 ~ 14 |
| Surface Treatment | S.L.A (Sand-blasted Large gritAcid-etched) | S.L.A (Sand-blasted Large gritAcid-etched) |
| Sterilization Method | Gamma | Gamma |
| Abutment | ||
| Diameters(mm) | 4.0 ~ 7.5 | 4.5 ~ 7.5 |
| Abutment Cuff Lengths(mm) | 1.5 ~ 5.5 | 1.0 ~ 5.5 |
| Abutment Angulation(") | Max. 25° | Max. 25° |
| Abutment Surface Treatment | Machined type | TiN Coating |
| Abutment Sterilization Method | Non Sterilization | Non Sterilization |
| Abutment Material | CP Ti Gr3, Gr4 (ASTM F67)Ti Alloy(ASTM F136:Ti-6Al-4V ELI) | CP Ti Gr2, Gr3, Gr4 (ASTM F67) |
| Attachments | Various abutments and components | Various abutments and components |
{3}------------------------------------------------
Traditional 510(k) Submission
8. Indication for use -
The DIO UF HSA Internal Sub-Merged Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller (03.8 ~ (05.5) implants can be placed with a conventional two stage surgival process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading. The larger (06.0 ~ Ø7.0) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.
{4}------------------------------------------------
9. Review
The DIO UF HSA Internal Sub-Merged Implant System has same material and characteristics as design and technological the indication for used, similar predicate device.
The DIO UF HSA Internal Sub-Merged Implant System has been subjected to safety, performance and product validation prior to release. Safety tests including biocompatibility has been performed to ensure the devices comply with the applicable International and US regulations.
10. Summary of nonclinical testing
Fatigue testing was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the DIO HSA STEADY Internal Sub-Merged Fixture and an angled abutment.
Therefore, the fatigue test result of DIO UF HSA Internal Sub-Merged Implant System performs as intended.
11. Conclusion
The evaluation of the DIO UF HSA Internal Sub-Merged Implant System does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device.
3KC
Date : Feb/ 15/ 2013
Date : Feb/ 15/ 2013
Gab-moon,Jeong/ DIO Corporation RA Staff
signature
Tim C.J. Lee/ DIO, USA Manager
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized emblem that resembles an abstract caduceus or a symbol representing health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2013
DIO Corporation C/O Mr. Timothy C.J. Lee Manager DIO USA 3540 Wilshire Boulevard, #1104 LOS ANGELES CA 90010
Re: K122519
Trade/Device Name: DIO UF HSA Internal Sub-Merged Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: DZE, NHA Product Code: II Dated: May 6, 2013 Received: May 6, 2013
Dear Mr. Lee:
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 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/Resourcesfor You/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.
Kwame O. Ulmer -S 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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Attachment 2
Indications for Use Statement
510(K) Number (if known): _ K | 225| 9
Device Name : DIO UF HSA Internal Sub-Merged Implant System
Indications For Use:
The DIO UF HSA Internal Sub-Merged Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller (03.8 ~ (05.5) implants can be placed with a conventional two stage surgival process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading. The larger (Ø6.0 ~ Ø7.0) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.
Over-The-Counter Use AND/OR Prescription Use S (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE, ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by Mary S. Runner -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Mary S. Runner -S,
0.9.2342.19200300.100.1.1=1300087950
Date: 2013.05.21 10:55:10 -04'00'
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K122519 |
|---|---|
| ---------------- | --------- |
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Page 1 of 1
§ 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.