UF(II) Implant System

K170608 · Dio Corporation · DZE · Mar 30, 2018 · Dental

Device Facts

• Record ID: K170608
• Device Name: UF(II) Implant System
• Applicant: Dio Corporation
• Product Code: DZE · Dental
• Decision Date: Mar 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The UF(II) Implant System is an endosseous dental implant system consisting of titanium fixtures, abutments, and screws. The system is surgically placed into the upper or lower jaw arches by a dental professional to serve as a root form for prosthetic attachments (crowns, bridges). The fixture is made of Grade 4 titanium with an SLA (Sand-blasted, Large grit, Acid-etched) surface treatment to promote osseointegration. The device is used in a clinical setting; the clinician performs the surgical placement and subsequent prosthetic restoration. The system supports both two-stage surgical procedures (with transmucosal healing) and single-stage procedures (for immediate loading). The output is a stable foundation for dental prosthetics, which restores the patient's chewing function and aesthetic appearance. The system includes various abutment types (solid, cemented, conical, healing) and cover screws to manage the soft tissue and prosthetic connection.

Clinical Evidence

Bench testing only. Evidence includes sterilization validation (ISO 11137, ISO 17665), fatigue testing (ISO 14801), biocompatibility (ISO 10993 series, USP <151>), and mechanical testing (dimensional analysis, rotational angle, torque, static shear strength, and packaging integrity). No clinical data was required or provided.

Technological Characteristics

Materials: Commercially Pure Titanium Grade 4 (ASTM F67). Surface: SLA (Sand-blasted, Large grit, Acid-etched) for fixtures; TiN coating for some abutments. Sterilization: Gamma or steam. Design: Root-form endosseous dental implant with internal connection. Dimensions: Fixture diameters 3.8-5.5mm, lengths 7.0-16.0mm. Connectivity: Mechanical connection to abutments/superstructures.

Indications for Use

Indicated for surgical placement in upper and lower jaw arches to provide root form for single or multiple unit prosthetic attachment to restore chewing function. Suitable for conventional two-stage surgical process with transmucosal healing or single-stage process for immediate loading when primary stability is achieved. No specific age or gender restrictions noted.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• DIO UF HSA Internal Sub-merged Implant System (K122519)

Reference Devices

• Implantium II (K060501)
• UF(II) Narrow Implant System (K161987)
• SM Internal/External Implant System (K070569)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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.

K170608

# 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 [phone]

Fax [phone]

Contact / US agent: Peter Kang DIO USA. 3470 Wils hire Blvd. #620 Los Angeles, CA Phone [phone] Fax [phone]

## 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 Predicate<br>Device | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510K Number | K170608 | K122519 | |
| Device Name | UF(II) Implant System | DIO UF HSA Internal Sub-merged<br>Implant System | |
| Manufacturer | DIO Corporation | DIO Corporation | |
| Indications<br>for Use | The UF(II) Implant Systemis indicated<br>for surgical<br>placement in the upper and lower jaw<br>arches, to provide a root form means for<br>single or multiple units' prosthetic<br>attachment to restore a patient's chewing<br>function. The UF(II) Implant<br>System( $Ø$ 3.8~ $Ø$ 5.5) can be placed with<br>a conventional two stage surgical<br>process with an option for transmucosal<br>healing or they can be placed in a single<br>stage surgical process for immediate<br>loading when good primary stability is<br>achieved with appropriate occlusal<br>loading. | The DIO UF HSA Internal Sub-Merged<br>Implant Systemis indicated for surgical<br>placement in the upper and lower jaw<br>arches, to provide a root form means for<br>single or multiple units' prosthetic<br>attachment to restore a patient's chewing<br>function. The smaller ( $Ø$ 3.8~ $Ø$ 5.5)<br>implants can be placed with a<br>conventionaltwo stage surgical process<br>with an option for transmucosal healing<br>or they can be placed in a single stage<br>surgical process for immediate loading<br>when good primary stability is achieved<br>with appropriate occlusal loading. The<br>larger( $Ø$ 6.0 ~ $Ø$ 7.0) implants can be<br>placed with a conventionaltwo stage<br>surgical process with an option for<br>transmucosal healing and are indicated<br>for the molar region with delayed<br>loading. | |
| Design | Image: Implant Design | Image: Implant Design | |
| Material | CP Ti Grade 4<br>(ASTM F67) | CP Ti Grade 4<br>(ASTM F67) | |
| Sterilization | Gamma Sterilization | Gamma Sterilization | |
| Fixture Diameter<br>(mm) | 3.8~5.5 | 3.8~7.0 | |
| Fixture Length<br>(mm) | 7.0~16.0 | 7.0~16.0 | |
| Product Code | DZE, NHA | DZE, NHA | |
| Fixture<br>Surface Treatment | Sand-blasted, Large grit, Acid-etched<br>(S.L.A) | Sand-blasted, Large grit, Acid-etched<br>(S.L.A) | |
| Substantial<br>Equivalence<br>Comparison | The UF(II) Implant System is similar designs and dimensions, and has the same material,<br>intended use, and technological characteristics as the identified predicate device (K122519).<br>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 Internal<br>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<br>(Delivered non sterile) | | Steam Sterilization by user<br>(Delivered non sterile) | | |
| Surface Treatment | TiN Coated | | Machined Type | | |
| Intended Use | Cemented Abutment is an abutment that is<br>first secured to the dental implant with an<br>abutment screw. A crown (the dental prosthesis)<br>is then connected to the abutment with dental<br>cement. This is be used for making a final<br>artificial tooth to provide masticatory and<br>aesthetic functions. Cemented Abutment is<br>supplied non-sterile. | | Cemented Abutment is an abutment that is<br>first secured to the dental implant with an<br>abutment screw. A crown (the dental<br>prosthesis) is then connected to the abutment<br>with dental cement. This is be used for making<br>a final artificial tooth to provide masticatory<br>and aesthetic functions. Cemented Abutment is<br>supplied non-sterile. | | |
| Substantial<br>Equivalence<br>Comparison | The UF(II) Implant System Cemented Abutment is similar designs and dimensions, and has the<br>same material, intended use, and technological characteristics as the identified predicate device<br>(K122519). The difference in the surface treatment has been addressed by providing additional<br>recommended information and through biocompatibility. When compared with predicate device,<br>no new questions of substantial equivalence have been raised for the UF(II) Implant System<br>Cemented 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 Implant<br>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<br>(Delivered non sterile) | Steam Sterilization by user<br>(Delivered non sterile) |
| Surface Treatment | TiN Coated | Machined Type |
| Intended Use | Solid Abutment is intended for use in<br>conjunction with the fixture in partially or<br>fully edentulous mandibles and maxillae, in<br>support of single or multiple-unit cement<br>retained restorations. | Solid Abutment is intended for use in<br>conjunction with the fixture in partially or<br>fully edentulous mandibles and maxillae, in<br>support of single or multiple-unit cement<br>retained restorations. |
| Substantial<br>Equivalence<br>Comparison | The UF(II) Implant System Solid Abutment is similar designs and dimensions, and has the<br>same material, intended use, and technological characteristics as the identified predicate<br>device (K122519). The difference in the surface treatment has been addressed by<br>providing additional recommended information and through biocompatibility. When<br>compared with predicate device, no new questions of substantial equivalence have been<br>raised 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 Implant<br>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<br>fixture to protect the inner configuration of the<br>implant and to maintain, stabilize and form the<br>soft tissue during the healing process. | The Healing Abutment is intended for use with<br>fixture to protect the inner configuration of the<br>implant and to maintain, stabilize and form the<br>soft tissue during the healing process. |
| Substantial<br>Equivalence<br>Comparison | The UF(II) Implant System Healing Abutment is similar designs and dimensions, and has the<br>same material, intended use, and technological characteristics as the identified predicate device<br>(K122519). When compared with predicate device, no new questions of substantial equivalence<br>have 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 | Primary<br>Predicate Device | Reference Device |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | DIO Corporation | DIO Corporation | DIO Corporation |
| Trade Name | UF(II) Implant System | DIO UF HSA Internal Sub-<br>merged Implant System | UF(II) Narrow Implant System |
| 510(K) No. | K170608 | K122519 | K161987 |
| Material | Titanium Grade 4<br>(ASTM F67) | Titanium Grade 4<br>(ASTM F67) | Titanium Grade 4<br>(ASTM F67) |
| Design | Image: Yellow screw | Image: Grey screw | Image: Grey screw |
| Diameters<br>(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<br>Treatment | Anodizing | Anodizing | Anodizing |
| Intended Use | To protect exposed top of the<br>fixture, Cover screw is to be<br>used in a narrow tooth gap after<br>inserting the implant. A cover<br>screw is designed to be<br>completely covered by mucosa.<br>After an integration period, a<br>second surgery is required to<br>reflect the mucosa and place a<br>abutment. It is supplied to users<br>after gamma sterilization | To protect exposed top of the<br>fixture, Cover screw is to be<br>used in a narrow tooth gap after<br>inserting the implant. A cover<br>screw is designed to be<br>completely covered by mucosa.<br>After an integration period, a<br>second surgery is required to<br>reflect the mucosa and place a<br>abutment. It is supplied to users<br>after gamma sterilization | To protect exposed top of the<br>fixture, Cover screw is to be<br>used in a narrow tooth gap after<br>inserting the implant. A cover<br>screw is designed to be<br>completely covered by mucosa.<br>After an integration period, a<br>second surgery is required to<br>reflect the mucosa and place a<br>abutment. It is supplied to users<br>after gamma sterilization |
| Substantial<br>Equivalence<br>Comparison | The UF(II) Implant System Healing Abutment is same designs, dimensions, material, intended use, and<br>technological characteristics as the identified predicate device (K122519, K161987). When compared<br>with predicate device, no new questions of substantial equivalence have been raised for the UF(II)<br>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 | Primary<br>Predicate Device | Reference Device |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | DIO Corporation | DIO Corporation | Dentium Co., Ltd. |
| Trade Name | UF(II) Implant System | SM Internal/External Implant<br>System | Implantium II |
| 510(K) No. | K170608…