(394 days)
The UF(II) 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 UF(II) Implant System(Ø3.8 ~ Ø5.5) can be placed with a conventional two stage surgical 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.
UF(II) Fixture is made of pure titanium grade 4 (ASTM F67) and the surface treatment is done with SLA (Sand-blasted, Large grit, Acid-etched). The diameters of fixture are 3.8, 4.0, 4.5, 5.0, 5.5mmand the lengths of fixture are 7.0, 8.5, 10.0, 11.5, 13.0, 15.0,16.0mm in this system. All fixture lengths are available in all diameters, except for the 7.0mm length, which is not available in 3.8 or 4.0mm diameters. The abutments and superstructures consist of Healing Abutment, Cemented Abutment Screw, Cover Screw, Solid Abutment, Cemented Cylinder, Cylinder Screw and Conical Abutment.
The provided text describes a 510(k) summary for the UF(II) Implant System, which relies on demonstrating substantial equivalence to predicate devices rather than proving a specific performance metric against acceptance criteria in the way a clinical study for a novel device would. Therefore, much of the requested information regarding clinical study design, sample size, expert adjudication, MRMC studies, effect sizes, training sets, and ground truth establishment is not directly applicable or available in this document.
The document focuses on non-clinical testing to demonstrate that the device meets criteria of established standards and is substantially equivalent to predicate devices.
Here's an attempt to extract the closest available information based on your request, highlighting what is implicitly or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are meeting the criteria of the referenced standards and demonstrating substantial equivalence to predicate devices. The "reported device performance" is the outcome of non-clinical tests that conclude these criteria are met.
Non-Clinical Test Acceptance Criteria and Reported Performance for UF(II) Implant System
| Test Category | Acceptance Criteria (Standard Compliance & Equivalence) | Reported Device Performance |
|---|---|---|
| Sterilization Validation and Shelf Life Testing | Achieved Sterility Assurance Level (SAL) of 10^-6^ in accordance with ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO11737-1, ISO 11737-2 (for gamma) and ISO 17665-1, ISO 17665-2 (for steam). Shelf life testing according to ASTM F1980 (accelerated aging). | - SAL of 10^-6^ was achieved, and all testing requirements were met for both gamma and steam sterilization. - Accelerated aging shelf life testing was conducted according to ASTM F1980 for devices provided sterile (real-time testing ongoing to support results). |
| Fatigue Test | Compliance with ISO 14801:2007 (Dentistry-Implants-Dynamic fatigue test for Endosseous Dental Implants) and ISO 14801:2016. Testing performed on worst-case scenario as per FDA guidance. | - The subject device was tested and met the criteria of ISO 14801:2007 and ISO 14801:2016. - The worst-case scenario was chosen for testing. |
| Biocompatibility | Compliance with ISO 10993-1:2009 ("Biological evaluation of medical devices-Part 1: Evaluation and testing within risk management process") and FDA Guidance document "Use of International Standard ISO 10993-1..." for relevant tests (Sensitization, Acute systemic toxicity, Cytotoxicity, Intracutaneous Reactivity Test, Pyrogen Test, Implantation Test). Abutment and superstructure must raise no new biocompatibility issues compared to predicates. | Fixture: - Sensitization: Conducted according to ISO10993-10. - Acute systemic toxicity: Conducted according to ISO 10993-11. - Cytotoxicity: Conducted according to ISO10993-5. - Intracutaneous Reactivity Test: Conducted according to ISO 10993-10. - Pyrogen Test: Conducted according to USP<151>. - Implantation Test: Conducted according to ISO 10993-6. Abutment and Superstructure: - No new biocompatibility issues raised due to identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to predicate devices. No additional testing required. |
| Mechanical Testing | Confirm external appearance (smooth, no cracks/damage), dimensional analysis, measurement of fixture-to-abutment gap, rotational angle (no significant rotation), maximum/removal torque for screws, static shear strength (equivalent to ISO 14801), and adequate packaging. | - Appearance Test: Confirmed smooth external appearance without cracks or damage. - Dimension Test: Confirmed same fundamental technology through dimensional analysis. - Measurement of the gap between Fixture and abutment: Confirmed same fundamental technology through dimensions. - Rotational Angle Test: Confirmed no significant rotation for the subject device. - Maximum Torque for dental implant screw Test: Confirmed equivalent rotational torque. - Removal Torque for dental implant screw Test: Confirmed equivalent removal torque. - Static Shear Strength Test: Conducted according to ISO 14801, confirming equivalent static shear strength. - Packaging Test: Confirmed adequate and equivalent packaging. |
| Substantial Equivalence | The device is similar in design, dimensions, material, intended use, surface treatment, and technological characteristics to identified predicate devices (K122519, K161987, K060501, K070569), raising no new questions of substantial equivalence. | Documentation provided shows comparison tables demonstrating similarity to predicates. Differences (e.g., fixture diameter range, surface treatment for abutments) are addressed and stated not to raise new questions of substantial equivalence. |
Specific Information on Study Design (Not Applicable to this 510(k) submission)
As this is a 510(k) premarket notification primarily relying on substantial equivalence through non-clinical testing, there are no clinical studies of the type you describe (e.g., involving human readers, ground truth consensus for image interpretation, effect sizes of AI assistance). The document focuses on demonstrating that the device meets established engineering and biological safety standards, and is equivalent to previously cleared devices.
Therefore, the following points are not applicable to the provided document:
- Sample size used for the test set and the data provenance: Not applicable, as this refers to clinical test data. Non-clinical tests would use physical samples of the device components.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical assessment is not established in this type of submission.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as it pertains to clinical performance assessment. Ground truth for non-clinical tests would be established through reference standards, metrology, and validated test methods.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
March 30, 2018
DIO Corporation % Peter Kang Business, Manager DIO USA 3470 Wilshire Blvd, #620 Los Angeles, California 90010
Re: K170608
Trade/Device Name: UF(II) Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 24, 2018 Received: February 27, 2018
Dear Peter Kang:
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 of medical device-related 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the word "DIO" in a bold, sans-serif font, with a small circle above and to the right of the "O". Below the word "DIO" are the words "Implant Solution" in a smaller, sans-serif font. The entire logo is in gray.
Indication for Use
510(K) Number (if known): ____K170608
Device Name: UF(II) Implant System
Indications for Use:
The UF(II) 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 UF(II) Implant System(Ø3.8 ~ Ø5.5) can be placed with a conventional two stage surgical 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.
Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font, with "DI" in gray and the "O" in pink. A small pink circle is positioned above and to the right of the "O". Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font, also in gray.
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirement of 21 CFR part 807.92
Submitter:
DIO Corporatioin. Jiae Park 66 Centumseo-ro, Haeundae-gu, Busan, 48058 Republic of Korea Phone +82-51-745-7836
Fax +82-51-745-7781
Contact / US agent: Peter Kang DIO USA. 3470 Wils hire Blvd. #620 Los Angeles, CA Phone 213-365-2875 Fax 213-365-1595
Device Information:
Trade Name: UF(II) Implant System Classification Name: Endos seous Dental Implant Classification: Class II Product Code: DZE Secondary product code : NHA Regulation number: 21 CFR 872.3640 Date Prepared: 03/29/2018
General Description
UF(II) Fixture is made of pure titanium grade 4 (ASTM F67) and the surface treatment is done with SLA (Sand-blasted, Large grit, Acid-etched). The diameters of fixture are 3.8, 4.0, 4.5, 5.0, 5.5mmand the lengths of fixture are 7.0, 8.5, 10.0, 11.5, 13.0, 15.0,16.0mm in this system. All fixture lengths are available in all diameters, except for the 7.0mm length, which is not available in 3.8 or 4.0mm diameters. The abutments and superstructures consist of Healing Abutment, Cemented Abutment Screw, Cover Screw, Solid Abutment, Cemented Cylinder, Cylinder Screw and Conical Abutment.
The solid abutment is available in every length and diameter. The cemented abutment is available in every length and diameter, for both hex and non-hex types. The healing abutments are available in the diameters shown. The cover screw is available as follows: for Ø2.7mm. length 4.7 or 5.7mm; for Ø2.794mm, length 6.3 or 7.0mm; for Ø3.6mm, length 6.5 or 7.5mm; for Ø3.8mm, length 8.1 or 9.1mm. The conical abutment is available in multiple total lengths (7.5, 8.5, 8.8, 9.5, 9.8, or 10.8mm), with one upper length and one diameter only. The cemented cylinder is available as follows: for Ø4.95 and 5.8mm, length 8mm; for Ø6.4 and 6.9mm, length 9mm.
Indication For Use
The UF(II) Implant Systemis 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 UF(II) Implant System(Ø3.8 ~ Ø5.5) can be placed with a conventional two stage surgical 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.
Predicate devices
Primary Predicate Device : DIO UF HSA Internal Sub-merged Implant System(K122519) Reference Device : Implantium II (K060501) UF(II) Narrow Implant System- Fixture, UF(II) Narrow Implant System-Supers tructure(K161987) SM Internal/External Implant System(K070569)
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font, with "DI" in gray and the "O" in pink. A small pink circle is positioned above and to the right of the "O". Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font.
Substantial Equivalence Comparison
The UF(II) Implant Systemis similar designs and dimensions, and has the same material, intended use, surface treatment and technological characteristics as the identified primary predicate device (K122519). When compared with predicate device, no new questions of substantial equivalence have been raised for the UF(II) Implant System.
1. Fixture
| Subject Device | Primary PredicateDevice | ||
|---|---|---|---|
| 510K Number | K170608 | K122519 | |
| Device Name | UF(II) Implant System | DIO UF HSA Internal Sub-mergedImplant System | |
| Manufacturer | DIO Corporation | DIO Corporation | |
| Indicationsfor Use | The UF(II) Implant Systemis indicatedfor surgicalplacement in the upper and lower jawarches, to provide a root form means forsingle or multiple units' prostheticattachment to restore a patient's chewingfunction. The UF(II) ImplantSystem( $Ø$ 3.8~ $Ø$ 5.5) can be placed witha conventional two stage surgicalprocess with an option for transmucosalhealing or they can be placed in a singlestage surgical process for immediateloading when good primary stability isachieved with appropriate occlusalloading. | The DIO UF HSA Internal Sub-MergedImplant Systemis 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. The smaller ( $Ø$ 3.8~ $Ø$ 5.5)implants can be placed with aconventionaltwo stage surgical processwith an option for transmucosal healingor they can be placed in a single stagesurgical process for immediate loadingwhen good primary stability is achievedwith appropriate occlusal loading. Thelarger( $Ø$ 6.0 ~ $Ø$ 7.0) implants can beplaced with a conventionaltwo stagesurgical process with an option fortransmucosal healing and are indicatedfor the molar region with delayedloading. | |
| Design | Image: Implant Design | Image: Implant Design | |
| Material | CP Ti Grade 4(ASTM F67) | CP Ti Grade 4(ASTM F67) | |
| Sterilization | Gamma Sterilization | Gamma Sterilization | |
| Fixture Diameter(mm) | 3.8~5.5 | 3.8~7.0 | |
| Fixture Length(mm) | 7.0~16.0 | 7.0~16.0 | |
| Product Code | DZE, NHA | DZE, NHA | |
| FixtureSurface Treatment | Sand-blasted, Large grit, Acid-etched(S.L.A) | Sand-blasted, Large grit, Acid-etched(S.L.A) | |
| SubstantialEquivalenceComparison | The UF(II) Implant System is similar designs and dimensions, and has the same material,intended use, and technological characteristics as the identified predicate device (K122519).When compared with predicate device, no new questions of substantial equivalence have |
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font, with the "O" in pink and the rest of the letters in gray. Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font.
The differences in indications between the UF(II) Implant System and Primary predicate device (K122519) do not raise new questions of substantial equivalence because the lack of the last sentence for the subject device in comparison to the primary predicate is acceptable since this submission does not include the larger diameter sizes. Thus, the proposed indications do not increase risk nor change the intended use of the device and are found to be substantially equivalent.
2. Cemented Abutment
| Subject Device | Predicated Device | ||||
|---|---|---|---|---|---|
| Applicant | DIO Corporation | DIO Corporation | |||
| Trade Name | UF(II) Implant System | DIO UF HSA InternalSub-merged Implant System | |||
| 510(K) No. | K170608 | K122519 | |||
| Material | Titanium Grade 4(ASTM F67) | Titanium Grade 4(ASTM F67) | |||
| Hex | Non-Hex | Hex | Non-Hex | ||
| Design | Image: Hex design of subject device | Image: Non-Hex design of subject device | Image: Hex design of predicated device | Image: Non-Hex design of predicated device | |
| Diameters (mm) | 4.5/5.5/6.5/7.5 | 4.5/5.5/6.5/7.5 | 4.5/5.5/6.5/7.5 | 4.5/5.5/6.5/7.5 | |
| Lengths (mm) | 4.0/5.5/7.0 | 4.0/5.5/7.0 | 4.0/4.5/5.5/7.0 | 4.0/4.5/5.5/7.0 | |
| Sterile | Steam Sterilization by user(Delivered non sterile) | Steam Sterilization by user(Delivered non sterile) | |||
| Surface Treatment | TiN Coated | Machined Type | |||
| Intended Use | Cemented Abutment is an abutment that isfirst secured to the dental implant with anabutment screw. A crown (the dental prosthesis)is then connected to the abutment with dentalcement. This is be used for making a finalartificial tooth to provide masticatory andaesthetic functions. Cemented Abutment issupplied non-sterile. | Cemented Abutment is an abutment that isfirst secured to the dental implant with anabutment screw. A crown (the dentalprosthesis) is then connected to the abutmentwith dental cement. This is be used for makinga final artificial tooth to provide masticatoryand aesthetic functions. Cemented Abutment issupplied non-sterile. | |||
| SubstantialEquivalenceComparison | The UF(II) Implant System Cemented Abutment is similar designs and dimensions, and has thesame material, intended use, and technological characteristics as the identified predicate device(K122519). The difference in the surface treatment has been addressed by providing additionalrecommended information and through biocompatibility. When compared with predicate device,no new questions of substantial equivalence have been raised for the UF(II) Implant SystemCemented Abutment. |
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has the letters DIO in a bold sans-serif font, with the letters DI in gray and the letter O in pink. There is a small pink circle above and to the right of the pink O. Below the letters, the words "Implant Solution" are written in a smaller, gray sans-serif font.
3. Solid Abutment
| Subject Device | Predicated Device | |
|---|---|---|
| Applicant | DIO Corporation | DIO Corporation |
| Trade Name | UF(II) Implant System | DIO UF HSA Internal Sub-merged ImplantSystem |
| 510(K) No. | K170608 | K122519 |
| Material | Titanium Grade 4(ASTM F67) | Titanium Grade 4(ASTM F67) |
| Design | Image: Two dental implants | Image: Dental implant |
| Diameters (mm) | 4.5/5.5/6.5/7.5 | 4.5/5.5/6.5/7.5 |
| Lengths (mm) | 4.0/5.5/7.0 | 4.0/5.5/7.0 |
| Sterile | Steam Sterilization by user(Delivered non sterile) | Steam Sterilization by user(Delivered non sterile) |
| Surface Treatment | TiN Coated | Machined Type |
| Intended Use | Solid Abutment is intended for use inconjunction with the fixture in partially orfully edentulous mandibles and maxillae, insupport of single or multiple-unit cementretained restorations. | Solid Abutment is intended for use inconjunction with the fixture in partially orfully edentulous mandibles and maxillae, insupport of single or multiple-unit cementretained restorations. |
| SubstantialEquivalenceComparison | The UF(II) Implant System Solid Abutment is similar designs and dimensions, and has thesame material, intended use, and technological characteristics as the identified predicatedevice (K122519). The difference in the surface treatment has been addressed byproviding additional recommended information and through biocompatibility. Whencompared with predicate device, no new questions of substantial equivalence have beenraised for the UF(II) Implant System Solid Abutment. |
{7}------------------------------------------------
4. Healing Abutment
| Subject Device | Predicated Device | |
|---|---|---|
| Applicant | DIO Corporation | DIO Corporation |
| Trade Name | UF(II) Implant System | DIO UF HSA Internal Sub-merged ImplantSystem |
| 510(K) No. | K170608 | K122519 |
| Material | Titanium Grade 4(ASTM F67) | Titanium Grade 4(ASTM F67) |
| Design | Image: Subject Device Design | Image: Predicated Device Design |
| Diameters (mm) | 4.6/4.7/5.6/6.6/7.6 | 4.0/4.5/5.0/5.5/6.5/7.5 |
| Sterile | Gamma Sterilization | Gamma Sterilization |
| Surface Treatment | Machined Type | Machined Type |
| Intended Use | The Healing Abutment is intended for use withfixture to protect the inner configuration of theimplant and to maintain, stabilize and form thesoft tissue during the healing process. | The Healing Abutment is intended for use withfixture to protect the inner configuration of theimplant and to maintain, stabilize and form thesoft tissue during the healing process. |
| SubstantialEquivalenceComparison | The UF(II) Implant System Healing Abutment is similar designs and dimensions, and has thesame material, intended use, and technological characteristics as the identified predicate device(K122519). When compared with predicate device, no new questions of substantial equivalencehave been raised for the UF(II) Implant System Healing Abutment. |
T
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font. The "DI" is in gray, while the "O" is in pink and has a small circle above and to the right of it. Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font.
5. Cover Screw
| Subject Device | PrimaryPredicate Device | Reference Device | |
|---|---|---|---|
| Applicant | DIO Corporation | DIO Corporation | DIO Corporation |
| Trade Name | UF(II) Implant System | DIO UF HSA Internal Sub-merged Implant System | UF(II) Narrow Implant System |
| 510(K) No. | K170608 | K122519 | K161987 |
| Material | Titanium Grade 4(ASTM F67) | Titanium Grade 4(ASTM F67) | Titanium Grade 4(ASTM F67) |
| Design | Image: Yellow screw | Image: Grey screw | Image: Grey screw |
| Diameters(mm) | 2.7/2.794/3.6/3.8 | 3.6/3.8 | 2.7/2.794 |
| Length (mm) | 4.7/5.7/6.3/6.5/7.3/7.5/8.1/9.1 | 6.5/7.5/8.1/9.1 | 4.7/5.7/6.3/7.3 |
| Sterile | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| SurfaceTreatment | Anodizing | Anodizing | Anodizing |
| Intended Use | To protect exposed top of thefixture, Cover screw is to beused in a narrow tooth gap afterinserting the implant. A coverscrew is designed to becompletely covered by mucosa.After an integration period, asecond surgery is required toreflect the mucosa and place aabutment. It is supplied to usersafter gamma sterilization | To protect exposed top of thefixture, Cover screw is to beused in a narrow tooth gap afterinserting the implant. A coverscrew is designed to becompletely covered by mucosa.After an integration period, asecond surgery is required toreflect the mucosa and place aabutment. It is supplied to usersafter gamma sterilization | To protect exposed top of thefixture, Cover screw is to beused in a narrow tooth gap afterinserting the implant. A coverscrew is designed to becompletely covered by mucosa.After an integration period, asecond surgery is required toreflect the mucosa and place aabutment. It is supplied to usersafter gamma sterilization |
| SubstantialEquivalenceComparison | The UF(II) Implant System Healing Abutment is same designs, dimensions, material, intended use, andtechnological characteristics as the identified predicate device (K122519, K161987). When comparedwith predicate device, no new questions of substantial equivalence have been raised for the UF(II)Implant System Cover screw. |
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has the letters DIO in gray, with the O in DIO being pink. Below the letters is the text "Implant Solution" in a smaller font.
6. Conical Abutment
| Subject Device | PrimaryPredicate Device | Reference Device | |
|---|---|---|---|
| Applicant | DIO Corporation | DIO Corporation | Dentium Co., Ltd. |
| Trade Name | UF(II) Implant System | SM Internal/External ImplantSystem | Implantium II |
| 510(K) No. | K170608 | K070569 | K060501 |
| Material | Titanium Grade 4(ASTM F67) | Titanium Grade 3(ASTM F67) | Titanium Grade 4(ASTM F67) |
| Design | Image: Conical Abutment | Image: Conical Abutment | Image: Conical Abutment |
| Diameters(mm) | 4.8 | 4.8/5.5 | 4.5/5.5 |
| UpperLength (mm) | 2.2 | 2.0/3.0/4.0/5.0 | - |
| SurfaceTreatment | Machined Type | Machined Type | TiN Coated |
| Sterile | end-user sterilized | end-user sterilized | end-user sterilized |
| Intended Use | Conical Abutment is intended foruse in conjunction with the fixturein partially or fully edentulousmandibles and maxillae, in supportof multiple-unit cement retainedrestorations. | Conical Abutment is intended foruse in conjunction with the fixturein partially or fully edentulousmandibles and maxillae, in supportof single or multiple-unit cementretained restorations. | Screw Abutment is intendedfor use in conjunction withthe fixture in partially orfully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitcement retained restorations. |
| SubstantialEquivalenceComparison | The UF(II) Implant System Conical Abutment is similar designs, dimensions, intended use, andtechnological characteristics as the identified predicate device (K070569, K060501).When compared with predicate device, no new questions of substantial equivalence have been raised forthe UF(II) Implant System Conical Abutment. |
7. Cemented Cylinder
| Subject Device | PrimaryPredicate Device | |
|---|---|---|
| Applicant | DIO Corporation | DIO Corporation |
| Trade Name | UF(II) Implant System | DIO UF HSA Internal Sub-merged ImplantSystem |
| 510(K) No. | K170608 | K122519 |
| Material | Commercially Pure TitaniumGrade 4 (ASTM F67) | Commercial Pure TitaniumGrade 4 ASTM F67 |
| Design | Image: Implant Design | Image: Implant Design |
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font, with the "O" in pink and the rest of the letters in gray. Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font, also in gray. The pink "O" has a small pink circle above it.
| Diameters(mm) | 4.95/5.8/6.4/6.9 | 5.0/5.8/6.4/6.9 |
|---|---|---|
| UpperLength (mm) | 8/9 | 8/9 |
| ConnectionPlatform | Non Octa | Non Octa |
| SurfaceTreatment | Machined Type | Machined Type |
| Sterile | end-user sterilized | end-user sterilized |
| Intended Use | The intended use of Cemented cylinder is samewith cemented abutment. But the shape is differentwith Cemented abutment. And it should be usedwith Octa abutment and Conical Abutment. | The intended use of Cemented cylinder is samewith cemented abutment. But the shape is differentwith Cemented abutment. And it should be usedwith Octa abutment and Conical Abutment. |
| SubstantialEquivalenceComparison | The UF(II) Implant System Cemented cylinder is similar designs, dimensions, intended use, andtechnological characteristics as the identified predicate device (K122519).When compared with predicate device, no new questions of substantial equivalence have been raised forthe UF(II) Implant System Cemented cylinder |
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font. The "D" and "I" are in gray, while the "O" is in pink with a small pink circle above and to the right of it. Below the letters, in a smaller font, are the words "Implant Solution" in gray.
Non-Clinical Test Data
The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device. This testing included:
Sterilization Validation and Shelf Life Testing
Sterilization validating testing has been performed in accordance with ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO11737-1, and ISO 11737-2 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization. Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.
For the subject devices provided sterile, accelerated aging shelf life testing was conducted according to ASTM F1980; real time testing is being conducted to support accelerated aging results.
Fatigue Test
The fatigue test was performed on the subject device in accordance with ISO 14801:2007 Dentisty-Implants-Dynamic fatigue test for Endosseous Dental Implants. The worst case scenario was chosen based on the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
The subject device was tested to evaluate its substantial equivalence according to the following standards. - Fatigue Test according to ISO 14801:2016
Biocompatibility
Biocompatibility testing was conducted according to ISO 10993-1:2009"Biological evaluation of medical devices-Part 1: Evaluation and testing within risk management process" and the biocompatibility evaluation flow chart according to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on:June 16, 2016" for each of the subject devices.
Fixture has been conducted the following biocompatibility test:
- Sensitization according to ISO10993-10
- Acute systemic toxicity according to ISO 10993-11
- Cytotoxicity according to ISO10993-5
- Intracutaneous Reactivity Test according to ISO 10993-10
- PyrogenTest according to USP<151>
- Implantation Test according to ISO 10993-6
Abutment and superstructure have the identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to the primary and reference devices. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.
Mechanical Testing
The following tests were conducted to demonstrate substantial equivalence to the predicate device: Appearance Test confirm external appearance of subject device (smooth without crack or damage) Dimension Test - confirm same fundamental technology through dimensional analysis Measurement of the gap between Fixture and abutment - confirm same fundamental technology through dimensions Rotational Angle Test - confirm that the subject device will not significantly rotate Maximum Torque for dental implant screw Test - confirm equivalent rotational torque Removal Torque for dental implant screw Test - confirm equivalent removal torque Static Shear Strength Test according to ISO 14801 - confirm equivalent static shear strength Packaging Test - confirm that the packaging is adequate and equivalent
Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, DIO Corporation concludes that the UF(II) Implant system is substantially equivalent to predicate devices as described herein.
§ 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.