(394 days)
No
The summary describes a dental implant system made of titanium with various components and dimensions. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are focused on mechanical and biological properties, not algorithmic performance.
Yes
The device is indicated for restoring a patient's chewing function, which addresses a pathological condition (loss of function) and improves health.
No
The device description and intended use indicate it is an implant system used for restoring chewing function, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is a physical implant system made of titanium with various hardware components (fixtures, abutments, screws).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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." This describes a surgical implant used in vivo (within the body) for structural support and function restoration.
- Device Description: The description details the materials (titanium), surface treatment, dimensions, and components (fixture, abutments, screws) of a physical implant and its associated parts.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Data:
- Sterilization Validation and Shelf Life Testing: 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 demonstrated SAL of 10-6 was achieved and all testing requirements were met. Accelerated aging shelf life testing was conducted according to ASTM F1980; real time testing is being conducted.
- Fatigue Test: Performed according to ISO 14801:2007 and ISO 14801:2016 for endosseous dental implants. Worst case scenario chosen based on FDA guidance.
- Biocompatibility: Conducted according to ISO 10993-1:2009 and FDA Guidance document "Use of International Standard ISO 10993-1..." for each subject device. Fixture underwent Sensitization (ISO10993-10), Acute systemic toxicity (ISO 10993-11), Cytotoxicity (ISO10993-5), Intracutaneous Reactivity Test (ISO 10993-10), PyrogenTest (USP), and Implantation Test (ISO 10993-6). Abutment and superstructure had identical body contact, duration, material formulation, manufacturing, and sterilization compared to predicate devices, thus no additional biocompatibility testing was required.
- Mechanical Testing: Conducted to demonstrate substantial equivalence: Appearance Test, Dimension Test, Measurement of the gap between Fixture and abutment, Rotational Angle Test, Maximum Torque for dental implant screw Test, Removal Torque for dental implant screw Test, Static Shear Strength Test (ISO 14801), Packaging Test.
Key results: The non-clinical testing demonstrates that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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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
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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)
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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)
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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 Predicate
Device | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510K Number | K170608 | K122519 | |
| Device Name | UF(II) Implant System | DIO UF HSA Internal Sub-merged
Implant System | |
| Manufacturer | DIO Corporation | DIO Corporation | |
| Indications
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( $Ø$ 3.8~ $Ø$ 5.5) 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. | The DIO UF HSA Internal Sub-Merged
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 smaller ( $Ø$ 3.8~ $Ø$ 5.5)
implants can be placed with a
conventionaltwo 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. The
larger( $Ø$ 6.0 ~ $Ø$ 7.0) implants can be
placed with a conventionaltwo stage
surgical process with an option for
transmucosal healing and are indicated
for the molar region with delayed
loading. | |
| 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) | 3.85.5 | 3.87.0 | |
| Fixture Length
(mm) | 7.016.0 | 7.016.0 | |
| Product Code | DZE, NHA | DZE, NHA | |
| Fixture
Surface Treatment | Sand-blasted, Large grit, Acid-etched
(S.L.A) | Sand-blasted, Large grit, Acid-etched
(S.L.A) | |
| Substantial
Equivalence
Comparison | 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 | | |
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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 Internal | |||
| Sub-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 is | ||||
| first secured to the dental implant with an | |||||
| abutment screw. A crown (the dental prosthesis) | |||||
| is then connected to the abutment with dental | |||||
| cement. This is be used for making a final | |||||
| artificial tooth to provide masticatory and | |||||
| aesthetic functions. Cemented Abutment is | |||||
| supplied non-sterile. | Cemented Abutment is an abutment that is | ||||
| first secured to the dental implant with an | |||||
| abutment screw. A crown (the dental | |||||
| prosthesis) is then connected to the abutment | |||||
| with dental cement. This is be used for making | |||||
| a final artificial tooth to provide masticatory | |||||
| and aesthetic functions. Cemented Abutment is | |||||
| supplied non-sterile. | |||||
| Substantial | |||||
| Equivalence | |||||
| Comparison | The UF(II) Implant System Cemented Abutment is similar designs and dimensions, and has the | ||||
| same material, intended use, and technological characteristics as the identified predicate device | |||||
| (K122519). The difference in the surface treatment has been addressed by providing additional | |||||
| recommended information and through biocompatibility. When compared with predicate device, | |||||
| no new questions of substantial equivalence have been raised for the UF(II) Implant System | |||||
| Cemented Abutment. |
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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 Implant |
| System | ||
| 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 in | |
| conjunction with the fixture in partially or | ||
| fully edentulous mandibles and maxillae, in | ||
| support of single or multiple-unit cement | ||
| retained restorations. | Solid Abutment is intended for use in | |
| conjunction with the fixture in partially or | ||
| fully edentulous mandibles and maxillae, in | ||
| support of single or multiple-unit cement | ||
| retained restorations. | ||
| Substantial | ||
| Equivalence | ||
| Comparison | The UF(II) Implant System Solid Abutment is similar designs and dimensions, and has the | |
| same material, intended use, and technological characteristics as the identified predicate | ||
| device (K122519). The difference in the surface treatment has been addressed by | ||
| providing additional recommended information and through biocompatibility. When | ||
| compared with predicate device, no new questions of substantial equivalence have been | ||
| raised for the UF(II) Implant System Solid Abutment. |
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4. Healing Abutment
| Subject Device | Predicated Device | |
|---|---|---|
| Applicant | DIO Corporation | DIO Corporation |
| Trade Name | UF(II) Implant System | DIO UF HSA Internal Sub-merged Implant |
| System | ||
| 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 with | |
| fixture to protect the inner configuration of the | ||
| implant and to maintain, stabilize and form the | ||
| soft tissue during the healing process. | The Healing Abutment is intended for use with | |
| fixture to protect the inner configuration of the | ||
| implant and to maintain, stabilize and form the | ||
| soft tissue during the healing process. | ||
| Substantial | ||
| Equivalence | ||
| Comparison | The UF(II) Implant System Healing Abutment 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 been raised for the UF(II) Implant System Healing Abutment. |
T
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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 | Primary
Predicate 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 |
| Surface
Treatment | Anodizing | Anodizing | Anodizing |
| Intended Use | To protect exposed top of the
fixture, Cover screw is to be
used in a narrow tooth gap after
inserting the implant. A cover
screw is designed to be
completely covered by mucosa.
After an integration period, a
second surgery is required to
reflect the mucosa and place a
abutment. It is supplied to users
after gamma sterilization | To protect exposed top of the
fixture, Cover screw is to be
used in a narrow tooth gap after
inserting the implant. A cover
screw is designed to be
completely covered by mucosa.
After an integration period, a
second surgery is required to
reflect the mucosa and place a
abutment. It is supplied to users
after gamma sterilization | To protect exposed top of the
fixture, Cover screw is to be
used in a narrow tooth gap after
inserting the implant. A cover
screw is designed to be
completely covered by mucosa.
After an integration period, a
second surgery is required to
reflect the mucosa and place a
abutment. It is supplied to users
after gamma sterilization |
| Substantial
Equivalence
Comparison | The UF(II) Implant System Healing Abutment is same designs, dimensions, material, intended use, and
technological characteristics as the identified predicate device (K122519, K161987). When compared
with predicate device, no new questions of substantial equivalence have been raised for the UF(II)
Implant System Cover screw. | | |
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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 | Primary
Predicate Device | Reference Device |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | DIO Corporation | DIO Corporation | Dentium Co., Ltd. |
| Trade Name | UF(II) Implant System | SM Internal/External Implant
System | 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 |
| Upper
Length (mm) | 2.2 | 2.0/3.0/4.0/5.0 | - |
| Surface
Treatment | Machined Type | Machined Type | TiN Coated |
| Sterile | end-user sterilized | end-user sterilized | end-user sterilized |
| Intended Use | Conical Abutment is intended for
use in conjunction with the fixture
in partially or fully edentulous
mandibles and maxillae, in support
of multiple-unit cement retained
restorations. | Conical Abutment is intended for
use in conjunction with the fixture
in partially or fully edentulous
mandibles and maxillae, in support
of single or multiple-unit cement
retained restorations. | Screw Abutment is intended
for use in conjunction with
the fixture in partially or
fully edentulous mandibles
and maxillae, in support of
single or multiple-unit
cement retained restorations. |
| Substantial
Equivalence
Comparison | The UF(II) Implant System Conical Abutment is similar designs, dimensions, intended use, and
technological characteristics as the identified predicate device (K070569, K060501).
When compared with predicate device, no new questions of substantial equivalence have been raised for
the UF(II) Implant System Conical Abutment. | | |
7. Cemented Cylinder
| | Subject Device | Primary
Predicate Device |
|------------|--------------------------------------------------|--------------------------------------------------|
| Applicant | DIO Corporation | DIO Corporation |
| Trade Name | UF(II) Implant System | DIO UF HSA Internal Sub-merged Implant
System |
| 510(K) No. | K170608 | K122519 |
| Material | Commercially Pure Titanium
Grade 4 (ASTM F67) | Commercial Pure Titanium
Grade 4 ASTM F67 |
| Design | Image: Implant Design | Image: Implant Design |
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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 |
|---|---|---|
| Upper | ||
| Length (mm) | 8/9 | 8/9 |
| Connection | ||
| Platform | Non Octa | Non Octa |
| Surface | ||
| Treatment | Machined Type | Machined Type |
| Sterile | end-user sterilized | end-user sterilized |
| Intended Use | The intended use of Cemented cylinder is same | |
| with cemented abutment. But the shape is different | ||
| with Cemented abutment. And it should be used | ||
| with Octa abutment and Conical Abutment. | The intended use of Cemented cylinder is same | |
| with cemented abutment. But the shape is different | ||
| with Cemented abutment. And it should be used | ||
| with Octa abutment and Conical Abutment. | ||
| Substantial | ||
| Equivalence | ||
| Comparison | The UF(II) Implant System Cemented cylinder is similar designs, dimensions, intended use, and | |
| technological characteristics as the identified predicate device (K122519). | ||
| When compared with predicate device, no new questions of substantial equivalence have been raised for | ||
| the UF(II) Implant System Cemented cylinder |
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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
- 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.