UF(II) Wide Fixture

K173975 · Dio Corporation · DZE · Jun 1, 2018 · Dental

Device Facts

• Record ID: K173975
• Device Name: UF(II) Wide Fixture
• Applicant: Dio Corporation
• Product Code: DZE · Dental
• Decision Date: Jun 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The UF(II) Wide Fixture 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 larger (Ø5.9 – Ø6.9mm) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

Device Story

The UF(II) Wide Fixture is a titanium, screw-form, root-form endosseous dental implant. It is surgically placed into the bone of the upper or lower jaw arches by a dental professional to provide a foundation for single or multiple prosthetic units (crowns, bridges, overdentures). The device restores chewing function in patients. It is designed for the molar region and utilizes a conventional two-stage surgical process with an option for transmucosal healing and delayed loading. The implant acts as a mechanical anchor for dental prosthetics.

Clinical Evidence

Bench testing only. Testing included sterilization validation (ISO 11137 series), shelf-life testing (ASTM F1980), fatigue testing (ISO 14801:2016), and mechanical testing (rotational angle, torque, static shear strength, acid residue, and component analysis). Biocompatibility data was leveraged from K122519, supplemented by new cytotoxicity testing.

Technological Characteristics

Material: Titanium Grade 4. Surface: SLA. Dimensions: Widths 5.9/6.4/6.9mm; Lengths 7/8.5/10/11.5/13mm. Sterilization: Gamma Irradiation. Mechanical testing per ISO 14801:2016. Packaging tested for integrity.

Indications for Use

Indicated for patients requiring dental restoration in upper or lower jaw arches; specifically for molar region placement using a two-stage surgical process with delayed loading.

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

• Rescue Dental Internal Implant System (K063216)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Underneath the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

DIO Corporation c/o Peter Kang Business. Manager DIO USA 3470 Wilshire Blvd, #620 Los Angeles, California 90010 June 1, 2018

Re: K173975

Trade/Device Name: UF(II) Wide Fixture Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: February 23, 2018 Received: March 5, 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.

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);

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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 comprehensive regulatory information about medical devices and radiation-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.

## Mary S. Runner -S

Tina Kiang, Ph.D. for 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 letters "DIO" in a bold, sans-serif font. The "DI" is 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".

# Indication for Use

510(K) Number (if known): K173975

Device Name: UF(II) Wide Fixture

#### Indications for Use:

The UF(II) Wide Fixture 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's chewing function. The larger (05.9 - 06.9mm) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

AND/OR Over The-Counter Use 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 gray, with the "O" stylized as a pink circle with a smaller pink circle above it. Below the letters, the words "Implant Solution" are written in a smaller, gray font.

K173975

# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirement of 21 CFR part 807.92

## Submitter:

Jiae Park DIO Corporatioin. 66 Centum seo-ro, Haeundae-gu, Busan, Republic of Korea Phone [phone] Fax [phone]

## Contact / US agent:

Peter Kang DIO USA. 3470 Wilshire Blvd. #620 Los Angeles, CA Phone [phone] Fax [phone]

## Device Information:

Trade Name: UF(II) Wide Fixture Classification Name: Endosseous Dental Implant Classification: Class II Product Code: DZE Regulation : 21 CFR 872.3640 Date Prepared: 05/31/2018

## General Description

UF(II) Wide Fixture is especially designed for use in dental implant surgery. It is intended to be surgically placed in the bone of the upper or lower jaw arches. It consists of titanium, screw-form, root-form endosseous dental implant.

## Indication For Use

The UF(II) Wide Fixture 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 larger (Ø5.9 – Ø6.9mm) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

## Predicate devices

Primary Predicate Device : DIO UF HSA Internal Sub-Merged Implant System(K122519) Reference Device : Rescue Dental Internal Implant System (K063216)

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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. The "DI" is in gray, while the "O" is in pink and has a small pink circle above and to the right of it. Below the letters, in a smaller font, are the words "Implant Solution".

## Substantial Equivalence Comparison

The UF(II) Wide Fixture is substantially equivalent in design, function, material and indications for use to Predicate device of K122519, K063216.

The UF(II) Wide Fixture has the same material, surface treatment and similar design to the Primary Predicate device as K122519, the similar with reference devices as K063216.

The Indications for Use listed for the Subject and Primary predicate devices (K122519) do not raise new questions of substantial equivalence because smaller diameter implants are not part of this submission and all the subject devices retain the same intended use. The Indications for Use were adequately modified to reflect this difference.

Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate.

| | Subject Device | Primary<br>Predicate Device | Reference device |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | DIO Corporation | DIO Corporation | Megagen Implant Co., Ltd. |
| Trade Name | UF(II) Wide Fixture | DIO UF HSA Internal Sub-<br>Merged Implant System | RESCUE INTERNAL<br>IMPLANT SYSTEM |
| Classification<br>Name | Endosseous Dental Implant<br>(872.3640) | Endosseous Dental Implant<br>(872.3640) | Endosseous Dental Implant<br>(872.3640) |
| 510(k) No. | Not yet assigned | K122519 | K063216 |
| Product Code | DZE | DZE | DZE |
| Class | II | II | II |
| Material | Titanium Gr4 | Titanium Gr4 | Titanium Gr4 |
| Surface | SLA | SLA | SLA |
| Width(Φ) | 5.9/6.4/6.9 | 6.0/6.5/7.0 | 5.0/6.0/6.5/7.0/8.0 |
| Length | 7/8.5/10/11.5/13 | 7/8.5/10.5/12.5/14.5 | 7/8.5/10/11.5/13 |
| Image | Image: Implant | Image: Implant | Image: Implant |
| Indications<br>For Use | The UF(II) Wide Fixture is<br>indicated for surgical<br>placement in the upper and<br>lower jaw arches, to<br>provide a root form means<br>for single or multiple units'<br>prosthetic attachment to<br>restore a patient's chewing<br>function. The larger (Ø5.9<br>– Ø6.9mm) implants can<br>be placed with a<br>conventional two stage<br>surgical process with an<br>option for transmucosal | The DIO UF HSA Internal<br>Sub-Merged Implant System<br>is indicated for surgical<br>placement in the upper and<br>lower jaw arches, to provide<br>a root form means for single<br>or multiple units' prosthetic<br>attachment to restore a<br>patient's chewing function.<br>The smaller (Ø3.8 ~ Ø5.5)<br>implants can be placed with<br>a conventional two stage<br>surgical process with an<br>option for transmucosal | The Rescue Internal Implant<br>System is intended to be<br>surgically placed in the<br>maxillary or mandibular<br>molar areas for the purpose<br>providing prosthetic support<br>for dental restorations<br>(Crown, bridges, and<br>overdentures) in partially of<br>fully edentulous individuals.<br>These implants are intended<br>to be used where smaller<br>implants have failed. |
| | healing and are indicated | healing or they can be | |
| | for the molar region with | placed in a single stage | |
| | delayed loading. | surgical process for | |
| | | immediate loading when | |
| | | good primary stability is | |
| | | achieved with appropriate | |
| | | occlusal loading. The larger | |
| | | ( $ Ø6.0 ~ Ø7.0 $ ) implants can | |
| | | be placed with a | |
| | | conventional two stage | |
| | | surgical process with an | |
| | | option for transmucosal | |
| | | healing and are | |
| | | indicated for the molar | |
| | | region with delayed loading. | |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |

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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 "D" and "I" in gray and the "O" in pink. Above the "O" is a small pink circle. Below the letters is the text "Implant Solution" in a smaller, gray, sans-serif font.

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Image /page/6/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 letters "DI" 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 result of non-clinical testing demonstrate that the results have met 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, ISO 11737-1, and ISO 11737-2 for gamma 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 and 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 14801:2016 Dentistry-Implants-Dynamic loading 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".

#### Biocompatibility

The Biocompatibility Test are leveraged from previous submission(K122519) such as Cytotoxicity test, Sensitization test, Irritation or Intracutaneous reactivity test, Systemic toxicity test, Sub-chronic toxicity test, Genotoxocity test and Implantation test. Also, new cytotoxicity test conducted for subject device has the same material, surface treatment, and manufacturing process as the Primary predicate device (K122519).

#### 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) DimensionTest - confirm same fundamental technology through dimensional analysis RotationalAngle Test - confirm that the subject device will not significantly rotate Maximum Torque for dental implant screwTest - confirm equivalent rotational torque Removal Torque for dental implant screwTest - confirm equivalent removal torque Static Shear Strength Test accordingto ISO 14801 .- confirm equivalent static shear strength Packaging Test - confirm that the packaging is adequate and equivalent Acid Residue Test - confirm that F-, Cl-, NO2-, NO3-, SO42-, Br- and PO43- should be less than 1ppm. Component analysis - confirm that no foreign materials are observed on the surface.

## 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) Wide Fixture is substantially equivalent to predicate devices as described herein.