UF(II) Anatomic abutment

K190048 · Dio Corporation · NHA · Sep 30, 2019 · Dental

Device Facts

• Record ID: K190048
• Device Name: UF(II) Anatomic abutment
• Applicant: Dio Corporation
• Product Code: NHA · Dental
• Decision Date: Sep 30, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The UF(II) Anatomic abutment is intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The abutment can be used in single tooth replacements and multiple tooth restorations.

Device Story

UF(II) Anatomic abutment is a pre-manufactured (stock) dental abutment used to support prosthetic reconstructions (crowns/bridges) on root-form endosseous dental implants. Features scalloped margins to follow gingival contour for esthetics. Available in straight and angled (5°, 18°) configurations. Fabricated from titanium alloy (ASTM F136). Delivered non-sterile; requires user steam sterilization before clinical use. Used by dental professionals in clinical settings to aid prosthetic rehabilitation. Output is a mechanical interface between the dental implant and the final prosthesis. Benefits include improved esthetic outcomes and support for chewing function restoration.

Clinical Evidence

Bench testing only. Includes fatigue testing per ISO 14801:2007 and sterilization validation per ISO 17665-1/2. Biocompatibility assessment leveraged from K122519 based on identical material, manufacturing, and contact nature.

Technological Characteristics

Material: Ti-6Al-4V ELI (ASTM F136). Design: Stock abutment with scalloped margins; straight or angled (5°, 18°). Dimensions: Diameters 4.21-6.14mm; gingival heights 1.5-5.5mm. Retention: Screw or cement-retained. Sterilization: User steam sterilization. Connectivity: Mechanical interface to endosseous dental implants.

Indications for Use

Indicated for patients requiring prosthetic reconstruction (crowns or bridges) supported by endosseous dental implants in single or multiple tooth restorations.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• P.004 RC Anatomic Abutments (K062129)

Reference Devices

• P.004 NC Anatomic abutment (K071357)
• Neodent Implant System CM Anatomic Abutment (K150199)
• DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM (K122519)

Submission Summary (Full Text)

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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 & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.

September 30, 2019

DIO Corporation % Peter Kang Business Manager DIO USA 3470 Wilshire Blvd, #620 Los Angeles, California 90010

Re: K190048

Trade/Device Name: UF(II) Anatomic abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 28, 2019 Received: August 30, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K190048

Device Name UF(II) Anatomic abutment

Indications for Use (Describe)

The UF(II) Anatomic abutment is intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The abutment can be used in single tooth replacements and multiple tooth restorations.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has the letters "DIO" in a sans-serif font, with "DI" in gray and "O" in pink with a small pink circle above and to the right of it. Below the letters is the text "Implant Solution" in a smaller, gray, sans-serif font.

# 510(k) Summary

# K190048

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

#### Submitter:

DIO Corporation JiAe, Park 66 Centum seo-ro, Haeundae-gu, Busan, 48058 Republic of Korea Phone [phone] Fax [phone]

# Contact / US agent:

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

## Device Information:

Trade Name: UF(II) Anatomic abutment Common Name: Endosseous dental implant abutment Classification Name: Abutment, Implant, Dental, Endosseous Product Code: NHA Panel: Dental Regulation Number: 21 CFR 872.3630 Device Class: Class II Date prepared: 09/26/2019

# General Description

The UF(II) Anatomic abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. The anatomic abutment has scalloped margins to follow the gingival contour to provide better esthetic results with the final prosthesis. It consist of straight abutment and angled of 5°, 18°, and are made from titanium alloy conforming to ASTM F136. The anatomic abutments are pre-manufactured (stock) abutments is provided non-sterile, this should be user steam sterilized before use.

#### Indication For Use

The UF(II) Anatomic abutment is intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The abutment can be used in single tooth replacements and multiple tooth restorations.

#### Predicate devices

The subject device is substantially equivalent to the following predicate and Reference Device: Primary Predicate Device : P.004 RC Anatomic Abutments (K062129) Reference Device : P.004 NC Anatomic abutment (K071357) Neodent Implant System CM Anatomic Abutment (K150199)

DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM (K122519)

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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 "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".

## Summaries of Technological Characteristics

The subject device is substantially equivalent of the are substantially equivalent in intended use, material and comection interfaces to the implants are identical for each individual diameter and connection demonstrating Substantial Equivalence follows:

| | Subject Device | Primary<br>Predicate Device | Reference Device | | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | DIO Corporation | Institut Straumann AG | Straumann US (on behalf of<br>Institut Straumann AG) | JJGC Industria E Comercio<br>De Materiais Dentarios SA | DIO Corporation |
| Trade Name | UF(II) Anatomic<br>abutment | P.004 RC Anatomic<br>Abutments | P.004 NC Anatomic<br>Abutment | Neodent Implant System | DIO UF HSA INTERNAL<br>SUB-MERGED IMPLANT<br>SYSTEM |
| 510(K) No. | K190048 | K062129 | K071357 | K150199 | K122519 |
| Classification<br>Name | Endosseous Dental<br>Implant, Abutment<br>(872.3630) | Endosseous Dental<br>Implant, Abutment<br>(872.3630) | Endosseous Dental Implant,<br>Abutment<br>(872.3630) | Endosseous Dental Implant,<br>Abutment<br>(872.3630) | Endosseous Dental Implant,<br>Abutment<br>(872.3630) |
| Product Code | NHA | NHA | NHA | NHA | NHA |
| Class | II | II | II | II | II |
| Material | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | - | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) |
| Design | Image: UF(II) Anatomic abutment | Image: P.004 RC Anatomic Abutments | Image: P.004 NC Anatomic Abutment | Image: Neodent Implant System | Image: DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM |
| Abutment<br>Diameters (mm) | 4.21/4.49/4.84/5.11/6.14 | 6.5 | 4.0 | 4.7/6.0 | 4.5/5.5 |
| | | | | | |
| Gingival heights | 1.5/2.5/3.5/4.5/5.5 | 2.0/3.5 | 2.0/3.5 | 1.5/2.5/3.5 | 1.5/2.0/3.0/4.0/5.0 |
| Angle | 5/18 | 0/15 | 0/15 | 0/17 | 15/25 |
| Sterile | Steam Sterilization by<br>user<br>(Delivered non sterile) | Steam Sterilization by<br>user<br>(Delivered non sterile) | Steam Sterilization by user<br>(Delivered non sterile) | Steam Sterilization by user<br>(Delivered non sterile) | Steam Sterilization by user<br>(Delivered non sterile) |
| Type of<br>Retention | Screw-retained or cement<br>retained | Screw-retained or cement<br>retained | Screw-retained or cement<br>retained | Screw-retained or cement<br>retained | Screw-retained or cement<br>retained |
| Intended Use | The UF(II) Anatomic<br>abutment is intended to be<br>placed into dental<br>implants to provide<br>support for prosthetic<br>reconstructions such as<br>crowns or bridges. The<br>abutment can be used in<br>single tooth replacements<br>and multiple tooth<br>restorations. | The P.004 Implants are<br>intended for immediate,<br>delayed or conventional<br>placement in the maxilla<br>and/or mandibular arches<br>to support crowns, bridges<br>or overdentures in<br>edentulous or partially<br>edentulous patients.<br>They are intended for<br>immediate function on<br>single-tooth and/or<br>multiple tooth<br>applications when good<br>primary stability is<br>achieved and with<br>appropriate occlusal<br>loading, to restore<br>chewing function.<br>Multiple tooth<br>applications may be<br>rigidly splinted. In the<br>case of edentulous | Abutments are intended to be<br>placed into dental implants<br>to provide support for<br>prosthetic reconstructions<br>such as crowns, bridges and<br>overdentures. Abutments can<br>be used in single tooth<br>replacements and multiple<br>tooth restorations. | CM Alvim Acqua Implant<br>The Neodent Implant System<br>is intended to be surgically<br>placed in the bone of the<br>upper or lower jaw to<br>provide support for<br>prosthetic devices such as<br>artificial teeth, to restore<br>chewing function. It may be<br>used with single-stage or<br>two-stage procedures, for<br>single or multiple unit<br>restorations, and may be<br>loaded immediately when<br>good primary stability is<br>achieved and with<br>appropriate occlusal loading.<br>Multiple tooth applications<br>may be rigidly splinted.<br>Facility Acqua Implant<br>The Neodent Implant System<br>is intended to be surgically<br>placed in the bone of the | 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 unit's prosthetic<br>attachment to restore a<br>patient's chewing function.<br>The smaller(Ø3.8~5.5)<br>implants can be placed with<br>a conventional two stage<br>surgical process with an<br>option for transmucosal<br>healing or they can be placed<br>in a single stage surgical<br>process with an option for<br>transmucosal healing or they<br>can be placed in a single<br>stage surgical process for<br>immediate loading when<br>good primary stability is<br>achieved with appropriate<br>occlusal loading. The |

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Image /page/5/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has the letters DIO in a sans-serif font, with the DI in gray and the O in pink. There is a small pink circle above the O. Below the letters is the text "Implant Solution" in a smaller, gray 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 "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, the words "Implant Solution" are written in a smaller, gray font.

| | implants must be used.<br>Abutments are intended<br>to be placed into dental<br>implants to provide<br>support for prosthetic<br>reconstructions such as<br>crowns or bridges. Meso<br>abutments are indicated<br>for cemented restorations<br>particularly in esthetic<br>areas of the mouth. The<br>abutment can be used in<br>single tooth replacements<br>and multiple tooth<br>restorations. | upper or lower jaw to<br>provide support for<br>prosthetic devices such as<br>artificial teeth, to restore<br>chewing function. It may be<br>used with single-stage or<br>two-stage procedures, for<br>single or multiple unit<br>restorations, and may be<br>loaded immediately when<br>good primary stability is<br>achieved and with<br>appropriate occlusal loading.<br>The Facility implant is<br>indicated for replacement of<br>maxillary lateral incisors,<br>mandibular incisors or<br>retention of overdentures. | larger(Ø6.0~7.0) implants<br>can be placed with a<br>conventional two stage<br>surgical process with an<br>option for transmucosal<br>healing and are indicated for<br>the molar region with<br>delayed loading. |
|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | CM Anatomic Abutment,<br>Exact Anatomic, Lateral<br>Anatomic, and Lateral<br>Anatomic Abutments<br>The Neodent Implant System<br>is intended to be surgically<br>placed in the bone of the<br>upper or lower jaw to<br>provide support for<br>prosthetic devices such as<br>artificial teeth, to restore<br>chewing function. It may be<br>used with single-stage or<br>two-stage procedures, for | |

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Image /page/7/Picture/1 description: The image shows the logo for DIO Implant Solution. The letters "DIO" are in a bold, sans-serif font, with the "O" in pink and the rest in gray. Above the "O" is a small pink circle. Below the logo is the text "Implant Solution" in a smaller, gray, sans-serif font.

| | | | | single or multiple unit<br>restorations, and may be<br>loaded immediately when<br>good primary stability is<br>achieved and with<br>appropriate occlusal loading. | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Substantial<br>Equivalence<br>Comparison | The UF(II) Anatomic abutment is substantially equivalent in designs, dimensions, material, indications, and technological characteristics with the<br>identified primary predicate device. The UF(II) Anatomic abutment is similar in fundamental scientific technology to the predicate device in that<br>they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-food<br>endosseous dental implants and endosseous dental implant abutments.<br>The diameters and angulation of the subject device are slightly different from the predicate devices. However, the subject diameters and angulations are<br>in the range of diameters and angulation of predicates.<br>The Indications for Use of the subject and primary predicate device are identical other than lack of the first sentence and middle sentence for fixture. It<br>is acceptable since the subject device is anatomic abutment only. Therefore, the indication related to fixture was excluded. Thus, the proposed<br>indications do not increase risk nor change the intended use of the device and are found to be substantially equivalent.<br>Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the<br>predicate and do not raise different questions of safety and effectiveness than the predicate. | | | | |

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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 stylized 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 gray font, are the words "Implant Solution."

# Non-clinical Testing

The results of the 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

Sterilization validating testing has been performed in accordance with 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. Sterilization was conducted in accordance with FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".

For the subject devices provided non-sterile status.

#### Fatigue Test

The fatigue test was performed on the subject device in accordance with ISO 14801:2007 Dentistry-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 14801:2007

## Biocompatibility

The Biocompatibility Test are leveraged from previous submission (K122519). Biocompatibility test conducted in accordance with 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". Abutments 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. 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".

Therefore, no additional biocompatibility testing was required.

#### Conclusions

The UF(II) Anatomic abutment constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, UF(II) Anatomic abutment send its predicates are substantially equivalent.

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