UNIdental Symphony Implant System

K221315 · Unidental Co., Ltd. · DZE · Oct 25, 2023 · Dental

Device Facts

• Record ID: K221315
• Device Name: UNIdental Symphony Implant System
• Applicant: Unidental Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Oct 25, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UNIdental Symphony Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The UNIdental Symphony Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

Device Story

Dental implant system comprising titanium fixtures and various abutments; surgically placed in maxilla or mandible to support prosthetic restorations; fixtures available in bone-level (Symphony 1) and tissue-level (Symphony 2) designs; Symphony 1 features tapered shape with self-tapping capability; Symphony 2 features round-end design; abutments support artificial teeth; used by dental surgeons in clinical settings; system facilitates soft tissue healing and restoration of mouth function; delayed loading protocol; provides stable foundation for fixed or removable prosthetics; benefits patients by restoring chewing function and aesthetics.

Clinical Evidence

No clinical data. Evidence consists of bench testing: biocompatibility (ISO 10993), sterilization validation (ISO 11137, ISO 17665), shelf-life (ASTM F1980), surface characterization (SEM/EDS), and mechanical fatigue testing (ISO 14801). MRI safety supported by literature review and adherence to ASTM F2052, F2213, F2182, and F2119.

Technological Characteristics

Materials: Titanium Grade 4 (ASTM F67), Ti-6Al-4V ELI (ASTM F136). Surface: SLA treatment. Sterilization: Gamma (fixtures) and steam (abutments). Design: Tapered/round-end fixtures with internal hex/octa connections. Connectivity: N/A (mechanical).

Indications for Use

Indicated for partially or fully edentulous adult patients requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support.

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

• SuperLine by Dentium Co., Ltd. (K160965)
• ITI Dental Implant System by Straumann (K031055)
• Straumann TLX Implant System by Straumann USA, LLC (K200586)
• SuperLine by Dentium Co., Ltd. (K213599)
• DentiumImplantium & SuperLine Prosthetics by Dentium Co., Ltd. (K172640)
• Multi-unit Abutment Plus by NOBEL BIOCARE AB (K161416)
• IMPLANTIUM ABUTMENTS by DENTIUM, INC. (K052823)

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 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.

October 25, 2023

UNIdental Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine. California 92612

Re: K221315

Trade/Device Name: UNIdental Symphony Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 29, 2023 Received: October 2, 2023

Dear Priscilla Chung:

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 (the 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 available 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.

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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,

Sherrill Lathrop Blitzer

for Andrew Steen Assistant Director

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DHT1B: Division of Dental and ENT 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)

# K221315

Device Name UNIdental Symphony Implant System

#### Indications for Use (Describe)

The UNIdental Symphony Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The UNIdental Symphony Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

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

| <div> <span style="font-size:14px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------|
| <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary (K221315)

This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 10/19/2023

### 1. Submitter

UNIdental Co., Ltd. #D-613 GM Techno-park, 60 Haan-ro, Gwangmyeong-si, Gyeonggi-do, 14322, Korea

Tel: [phone] Fax: [phone]

## 2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman STE 160, Irvine CA 92612 Fax: [phone] Phone: [phone] Email: juhee.c(@lkconsultinggroup.com

### 3. Device

- Trade Name: UNIdental Symphony Implant System ●
- Common Name: Dental Implant System
- Classification Name: Endosseous Dental Implant
- . Primary Product Code: DZE
- Secondary Product Code: NHA
- Classification regulation: 21CFR 872.3640

### 4. Predicate Device:

- Primary Predicate Device: ● SuperLine by Dentium Co., Ltd. (K160965)
- Reference Predicate Device: ● ITI Dental Implant System by Straumann (K031055) Straumann TLX Implant System by Straumann USA, LLC (K200586) SuperLine by Dentium Co., Ltd. (K213599) DentiumImplantium® &SuperLine® Prosthetics by Dentium Co., Ltd. (K172640)

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# Multi-unit Abutment Plus by NOBEL BIOCARE AB (K161416) IMPLANTIUM ABUTMENTS by DENTIUM, INC. (K052823)

## 5. Description:

The UNIdental Symphony Implant System is a dental implant system made of Titanium 6AL 4V ELI alloy and CP Ti Grade 4 intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. Symphony 1 Fixture is Bone level, and Symphony 2 Fixture is Tissue level.

Symphony 1 Fixture is a taper shape that gradually decreases the outer diameter of the lower part from the upper part.

And It is a taper shape that gradually decreases the outer diameter of the lower part from the upper part. It is a structure that can perform a tapping function at the same time without a separate tap. It couples up with the abutment and its hexagon shape.

Symphony 2 Fixture is a structure with a round shape at the end. It couples up with the abutment and its octagon shape. The area that touches the patient's gums is pure titanium surface.

| Implant Diameter | Symphony 1 Fixture | 3.6, 4.0, 4.5, 5.0, 5.8mm |
|------------------|--------------------|--------------------------------------------------|
| | Symphony 2 Fixture | 3.3, 4.1, 4.8mm |
| Implant Length | Symphony 1 Fixture | 7.0, 8.0, 10, 11.6, 12, 14mm |
| | Symphony 2 Fixture | 9.35, 10.35, 12.35, 14.35, 15.35, 16.35, 17.35mm |

The upper structure of the abutments support prosthetics such as artificial teeth to restore patient's total mouth function.

| Type | Description | Raw<br>Material | Diameter | Length | |
|----------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------------------------------------|-----------------------------------------------------------------------------|
| Healing<br>Abutment | Symphony 1 | The healing abutments provide the<br>framework forsoft tissue healing<br>and stability, which can achieve<br>the formation of anideal<br>emergence profile, prevent soft | Ti-6Al-<br>4V ELI | 4.1, 4.5,<br>5.0, 5.5,<br>6.5, 7.5,<br>8.5,<br>9.5mm | 9.5, 11, 12.5,<br>14.5mm |
| | Symphony 2 | tissuefrom overgrowing over the<br>implant fixture, and minimize the<br>possibility of a second surgery. | Ti-6Al-<br>4V ELI | 5.5,<br>7.2mm | 6.5,7.5, 9,<br>10.5, 12.5mm |
| Straight<br>Abutment | Symphony 1<br>(Dual<br>Abutment) | It is a general straight type<br>superstructure.<br>The dual abutment has the shape<br>of an inner crown and is an<br>abutment fixed with cement. | Ti-6Al-<br>4V ELI | 4.5, 5.5,<br>6.5mm | 8.2, 9.2, 9.7,<br>10.7, 11.2,<br>11.7, 12.2,<br>12.7, 13.2,<br>13.7, 14.2mm |

510(k) summary

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| | | The cemented abutment has the | | | 15.2mm |
|--------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------|--------------------------------------------------------------------------------------------------------|
| Angled<br>Abutment | Symphony 2<br>(Cemented<br>Abutment) | shape of an innercrown and is an<br>abutment that fixes the prosthesis<br>with dental cement, and the fixture<br>and connection part are hex. | Ti-6Al-<br>4V ELI | 3.5, 3.55,<br>4.3mm | 6.7, 8.2,<br>8.4mm |
| | Symphony 1 | It is used in case of the slope of<br>the prosthesis where the upper<br>part is not applicable.<br>TiN coating has been applied to<br>some items to prevent the metal<br>color from appearing black on the<br>gums. | Ti-6Al-<br>4V ELI<br>(TiN<br>Coating) | 4.5,<br>5.5mm | 12.76, 12.89,<br>13.01, 13.30,<br>13.79, 13.89,<br>14.01, 14.30,<br>14.79, 14.89,<br>15.01,<br>15.30mm |
| | Symphony 2 | Angled Abutment combined with<br>the Symphony 2 fixture has A type<br>and B type, and the only<br>difference between the two types<br>is the direction when fastening.<br>The allowed angulations are 15°<br>and 25°. | Ti-6Al-<br>4V ELI | 3.5,<br>4.3mm | 5.5, 6.5mm |
| | Multi-unit Straight<br>Abutment | This product is intended to be<br>used by edentulous patients in the<br>Overdenture case. | Ti-6Al-<br>4V ELI | 4.8mm | 8.2, 9.2, 9.3,<br>10.3, 11.3,<br>12.3mm |

### 6. Indication for use:

The UNIdental Symphony Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The UNIdental Symphony Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

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# 7. Basis for Substantial Equivalence

### 7.1 Fixture

| | Subject Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Name | UNIdental<br>Symphony Implant<br>System | SuperLine | ITI Dental Implant<br>System | Straumann TLX<br>ImplantSystem | SuperLine |
| 510(k) # | K221315 | K160965 | K031055 | K200586 | K213599 |
| Product<br>Code | DZE, NHA | DZE | DZE | DZE, NHA | DZE |
| Manufacturer | UNIdentalCo.,Ltd | DENTIUM CO., LTD. | Straumann | Straumann USA,<br>LLC (on behalf of<br>Institut Straumann<br>AG) | DENTIUM CO.,<br>LTD. |
| Indications<br>for Use | The UNIdental<br>Symphony Implant<br>System is indicated<br>for use in partially or<br>fully edentulous<br>mandibles and<br>maxillae, in support<br>of single or multiple-<br>unit restorations<br>including cemented<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and<br>terminal or<br>intermediate<br>abutment support for<br>fixed bridgework.<br>The UNIdental | SuperLine is indicated<br>for use in surgical and<br>restorative applications<br>for placement in the<br>bone of the upper or<br>lower jaw to provide<br>support for prosthetic<br>devices, such as<br>artificial teeth, in order<br>to restore the patient's<br>chewing function.<br>SuperLine is indicated<br>also for immediate<br>loading when good<br>primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. | ITI implants are<br>intended for surgical<br>placement in maxillary<br>and/or mandibular<br>arches to provide<br>support for prosthetic<br>in edentulous or<br>partially edentulous<br>patients. The ITI<br>Dental Implants are for<br>single-stage or two-<br>stage surgical<br>procedures. | Straumann TLX<br>Implantsare suitable<br>for<br>endostealimplantation<br>in the upperand lower<br>jaws and forthe<br>functional andesthetic<br>oral rehabilitationof<br>edentulous<br>andpartiallyedentulou<br>spatients. TLX<br>Implantscan be placed<br>withimmediate<br>function onsingle-<br>tooth and multi-<br>unitrestorations when<br>goodprimary stability<br>isachieved and<br>withappropriateocclus<br>alloading to<br>restorechewing<br>function. | SuperLine@ implants<br>are indicated for use<br>in surgical and<br>restorative<br>applications for<br>placement in the bone<br>of the upper or lower<br>jaw to provide<br>support for prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore the<br>patient's chewing<br>function. SuperLine@<br>implants are indicated<br>also for immediate<br>loading when good<br>primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. |
| | and two stage<br>surgical procedures.<br>It is intended for<br>delayed loading. | | | Theprosthetic<br>restorations<br>areconnected to the<br>implantsthroughtheco<br>rrespondingabutment<br>omponents. | implants are indicated<br>for delayed loading. |
| Implant<br>Design | Symphony 1Fixture<br>Image: Symphony 1 Fixture<br><br>Symphony 2 Fixture<br>Image: Symphony 2 Fixture | SuperLine Fixture<br>Image: SuperLine Fixture | Collar Type<br>Image: Collar Type | Straumann® TLXSP<br>Implant<br>Image: Straumann® TLXSP Implant | SuperLine FXSxxxx<br>Serie<br>Image: SuperLine FXSxxxx Serie |
| Implant<br>Diameter | Symphony<br>1Fixture<br>3.6 – 7.0mm<br><br>Symphony<br>2Fixture<br>3.3–4.8mm | 3.6 – 7.0 mm | 3.3 – 5.37 mm | Ø3.75, 4.0, 4.5, 5.0,<br>5.5,and 6.5 mm | 3.6/3.6; 4.0/4.0;<br>4.5/4.5; 5.0/5.0;<br>5.0/6.0; 5.8/7.0 mm |
| | Symphony<br>1Fixture<br>7.0 – 14.0mm<br><br>Symphony<br>2Fixture<br>9.35-17.35mm | 8.0 - 14.0 mm | 8.0 – 16.0 mm | Ø3.75, 4.0, 4.5, 5.0<br>mm:6, 8, 10, 12, 14,<br>16 and18 mm<br>Ø5.5 and 6.5 mm:6,<br>8, 10, 12 mm | Each in 7 mm length<br>only |
| Implant<br>Length | | | | | |
| Implant<br>Material | Fixture :Titanium<br>Grade 4<br>ASTM F 67 | Ti-6Al-4V ELI<br>ASTM F136 | Ti-6Al-4V ELI<br>ASTM F136 | Titanium-13<br>Zirconium alloy<br>(Roxolid®) | All implants:<br>unalloyed titanium,<br>ASTM F67 |
| Implant<br>Coating | Non-coated | Non-coated | Non-coated | Non-coated | Non-coated |

510(k) summary

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510(k) summary

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| Surface<br>Treatment | SLA Treatment | RBM(Calcium-<br>Phosphate Media) | RBM(Calcium-<br>Phosphate Media) | Hydrophilic<br>SLAactive® | All implants: S.L.A.,<br>Al2O3 blasted and<br>acid etched |
|------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------|-----------------------------------------------------------|
| Implant<br>Surface<br>Finish | Aluminum oxide<br>>99%<br>Sodium oxide<br><0.6%<br>Iron (III) oxide<br>< 0.2%<br>Silicon dioxide<br>< 0.1% | Calcium Phosphate :<br>Ha: >65%<br>Beta-TCP :<25%<br>Alpha-TCF :<5%<br>TTCP: <5%<br>Other CaP :<5% | Calcium Phosphate :<br>Ha: > 65%<br>Beta-TCP :<25%<br>Alpha-TCF :<5%<br>TTCP: <5%<br>Other CaP :<5% | - | - |
| Sterilization | Gamma Sterilization | Radiation sterilization | Radiation sterilization | Radiation sterilization | Gamma Sterilization |

The subject device is substantially equivalent to to SuperLine (K160965) by Dentium Co., Ltd.

They have the same indications for use and uses the same materials. The wording of the indications for use statement might be different but that of the subject device does not indications. It is written to elaborate on the indications more clearly.

The design is very similar, yet they may have some minor differences in design which does not raise a question in safety or performance. We have conducted a fatigue test and the subject device is substantially equivalent to the to the predicate device.

We identified references devices which compass the size range of the subject device.

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### 7.2. Abutments

| Subject Device | | Predicate Device | |
|----------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------|
| Device Name: | UNIdental Symphony Implant System | | Dentium Implantium® &<br>SuperLine® Prosthetics |
| 510(k) # | K221315 | | K172640 |
| Manufacturer | UNIdental Co.,Ltd. | | Dentium Co., Ltd. |
| Product Code | DZE, NHA | | NHA |
| Healing Abutments | | | |
| | Symphony 1 | Symphony 2 | |
| Design | Image: Symphony 1 Healing Abutment | Image: Symphony 2 Healing Abutment | Image: Predicate Device Healing Abutment |
| Abutment Materials | Ti 6Al 4V ELI,<br>Gr.23 | Ti 6Al 4V ELI, Gr.23 | Ti 6Al 4V ELI, Gr.23 |
| Intended Use | To help the soft<br>tissue of gum<br>naturally formed | To help the soft tissue<br>of gum naturally<br>formed | To help the soft tissue of gum<br>naturally formed. |
| Diameter<br>post heights | 4.1~9.5mm | 5.5~7.2mm | 4.0~9.5mm |
| gingival collar heights | 2.0~7.0mm | 2.0~7.0mm | 2.0~7.0mm |
| | 2~4mm | 2~4mm | 2~4mm |
| Surface Treatment | No | No | No |
| Sterilization | Steam Sterilization<br>by user | Steam Sterilization<br>by user | Steam Sterilization by user |
| Angled Abutment | | | |
| | Symphony 1 | Symphony 2 | |
| Design & Size Range | Image: Symphony 1 Angled Abutment<br>Angle : 15, 25<br>(Internal hex) | Image: Symphony 2 Angled Abutment<br>Angle : 15, 20<br>(Internal octa) | Image: Angled Abutment<br>Angle : 15, 25 |
| Abutment Materials | Ti 6Al 4V ELI,<br>Gr.23 | Ti 6Al 4V ELI, Gr.23 | Ti 6Al 4V ELI, Gr.23 |
| Intended Use | Structure of<br>abutment<br>lift the prosthesis | Structure of abutment<br>Lift the prosthesis | Structure of abutment<br>Lift the prosthesis |
| Diameter | 4.5~5.5mm | 3.5~4.3mm | 4.5~5.5mm |
| gingival collar heights<br>angulations | 1.5~3.5mm<br>Angle : 15, 25 | 1.5~3.5mm<br>Angle : 15, 20 | 1.5~3.5mm<br>Angle : 15, 25 |
| Surface Treatment | TiN coating - Gold<br>color (Partly) | No | No |
| Sterilization | Steam Sterilization<br>by user | Steam Sterilization by<br>user | Steam Sterilization by user |

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| Dual Abutment | | |
|-------------------------|--------------------------------------|-----------------------------------|
| Design & Size Range | Image: Dual Abutment (Internal hex) | Image: Dual Abutment |
| Abutment Materials | Ti 6Al 4V ELI,<br>Gr.23 | CP Ti Gr.4 |
| Intended Use | Cement retained<br>restoration | Cement retained restoration |
| Diameter | 4.5~6.5mm | 4.5~6.5mm |
| gingival collar heights | 1.0~5.5mm | 1.0~5.5mm |
| Surface Treatment | TiN coating - Gold<br>color (Partly) | TiN coating - Gold color (Partly) |
| Sterilization | Steam Sterilization<br>by user | Steam Sterilization by user |

The subject device is substantially equivalent to SuperLine (K160965) by Dentium Co., Ltd. They have the same indications for use and uses the same materials. The design is very similar, yet they may have some minor differences in design and dimension which does not raise a question in safety or performance. We have conducted a fatigue test and the results support that the subject device is substantially equivalent to the predicate device.

| | Subject Device | Predicate Device |
|---------------------|----------------------------------------------------|------------------------------------------------------------|
| Device Name: | UNIdental Symphony Implant System | Straumann TLX ImplantSystem |
| 510(k) # | K221315 | K200586 |
| Manufacturer | UNIdentalCo.,Ltd | DZE, NHA |
| Product Code | DZE, NHA | Straumann USA, LLC (on behalf of<br>Institut Straumann AG) |
| Design & Size Range | Image: Cemented Abutment (Internal screw retained) | Image: Abutments |
| Abutment Materials | Ti 6Al 4V ELI, Gr.23 | Titanium alloy |
| Intended Use | Cement retained restoration | Cement retained restoration |
| Diameter | 3.55~4.3mm | 3.5~5mm |
| post heights | 5.5mm | 5.7mm, 6mm |
| angulations | Angle : 0 | Angle : 0, 15 |
| Surface Treatment | No | No |
| Sterilization | Steam Sterilization by user | Steam Sterilization by user |

The subject device is substantially equivalent to to Straumann TLX ImplantSystem (K200586) by Straumann USA.

They have the same indications for use and uses the same materials. The design is very similar, yet they may have some minor differences in design which does not raise a question in safety or performance.

- Multi-unit Straight Abutment

510(k) summary

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| | Subject Device | | Predicate Device |
|-------------------------|-------------------------------------------------|-------------------------------------------------|----------------------------------------------|
| Device Name: | UNIdental Symphony Implant System | | Multi-unit Abutment Plus |
| 510(k) # | K221315 | | K161416 |
| Manufacturer | UNIdentalCo.,Ltd | | NOBEL BIOCARE AB |
| Product Code | DZE, NHA | | NHA |
| | Symphony 1 | Symphony 2 | |
| Design & Size Range | Image: Symphony 1 | Image: Symphony 2 | Image: Multi-unit Abutment Plus |
| Abutment Materials | Ti 6Al 4V ELI,<br>Gr.23 | Ti 6Al 4V ELI,<br>Gr.23 | Titanium vanadium alloy |
| Intended Use | Structure of<br>abutment<br>lift the prosthesis | Structure of<br>abutment<br>lift the prosthesis | Structure of abutment<br>lift the prosthesis |
| Diameter | 4.8mm | 4.8mm | 4.8mm |
| gingival collar heights | 1.0~5.0mm | 1.0~5.0mm | 1.5~4.5mm |
| angulations | Angle : 0 | Angle : 0 | Angle : 0, 17, 30 |
| Surface Treatment | No | No | No |
| Sterilization | Steam Sterilization<br>by user | Steam Sterilization<br>by user | Steam Sterilization by user |

The subject device is substantially equivalent to Multi-unit Abutment Plus (K161416) by NOBEL BIOCARE AB.

They have the same indications for use and uses the same materials. The design is very similar, yet they may have some minor differences in design which does not raise a question in safety or performance.

#### 7. 3. Screws

| | Subject Device | | Predicate Device |
|---------------|------------------------------------------|------------------------------------------|---------------------------------------|
| 510(K) Number | UNIdental Symphony Implant System | | IMPLANTIUM ABUTMENTS |
| Device Name | K221315 | | K052823 |
| Manufacturer | DZE, NHA | | DENTIUM, INC. |
| Product Code | UNIdental Co.,Ltd. | | NHA |
| Cover Screw | | | |
| | Symphony 1 | Symphony 2 | |
| Design | Image: Symphony 1 | Image: Symphony 2 | Image: Predicate Device |
| Intended Use | To provide sealing<br>effect for fixture | To provide sealing<br>effect for fixture | To provide sealing effect for fixture |

{13}------------------------------------------------

| Diameter | 3.6~6.0mm | 3.6~6.0mm | 3.8~5.8mm |
|----------------------|----------------------------------------------|----------------------------------------------|----------------------------------------|
| Material Composition | Ti 6A1 4V ELI,<br>Gr.23 | Ti 6A1 4V ELI,<br>Gr.23 | Ti 6Al 4V ELI, Gr.23 |
| Surface Treatment | No | No | Anodizing coloring(Entire Body) |
| Sterile | Steam Sterilization<br>by user | Steam Sterilization<br>by user | Radiation sterilization |
| Abutment Screw | | | |
| | Symphony 1 | Symphony 2 | |
| Design | Image: Abutment Screw Symphony 1 | Image: Abutment Screw Symphony 2 | Image: Abutment Screw |
| Intended Use | To connect the<br>abutment to the<br>fixture | To connect the<br>abutment to the<br>fixture | To connect the abutment to the fixture |
| Diameter | 2.0~2.4mm | 2.0~2.4mm | 2.3mm |
| Material Composition | Ti-6Al-4V ELI<br>ASTM F136 | Ti-6Al-4V ELI<br>ASTM F136 | Ti-6Al-4V ELI<br>ASTM F136 |
| Surface Treatment | No | No | No |
| Sterile | Steam Sterilization<br>by user | Steam Sterilization<br>by user | Steam Sterilization by user |

The subject device is substantially equivalent to toSuperLine (K160965) by Dentium Co., Ltd. They have the same indications for use and uses the same materials. The design is very similar, yet they may have some minor differences in design which does not raise a question in safety or performance. We have conducted a fatigue test and the results support that the subject device is substantially equivalent to the predicate device.

## 8. Non-Clinical Testing

- . Sterilization validating testing has been performed in accordance with ISO 11137 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization.
- . Shelf-life testing has been performed in according with ASTM F1980, ISO 11607, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and ISO 11737-2.
- . SEM (Scanning Electron Microscope) and EDS(Energy-dispersive X-ray spectroscopy) were performed to evaluate the fixture surface characteristics after SLA treatment.
- . Biocompatibility Tests were performed in accordance with ISO 10993-3, 5, 6, 10, and 11.
- Compressive load and fatigue tests in accordance with ISO 14801
- Bacterial Endotoxin Levels (LAL) in accordance with USP 85
- . MRI Safety
- A non-clinical worst-case MRI review was conducted to evaluate the UNIdental

{14}------------------------------------------------

Symphony Implant System in an MRI environment. Various dental journals were utilized to ensure its stability, and scientific evidence from literature was considered. such as the study by Yong-Ha Kim, Manki Choi, and Jae-Won Kim titled 'Are titanium implants actually safe for magnetic resonance imaging examinations?' (Arch Plast Surg 2019;46:96-97). The study concluded that titanium, being a paramagnetic material, is not affected by the magnetic field of MRI. The risk of implant-based complications is very low, and MRI can be safely used in patients with implants. Based on this paper, the stability of the raw material of the UNIdental Symphony Implant System in an MRI environment was confirmed.

In the study conducted by Woods, Terry O., Jana G. Delfino, and Sunder Rajan titled 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices' (Journal of Testing and Evaluation 49.2 (2019): 783-795). Titanium Grade 4 was evaluated using magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119) tests by T. O. Woods et al. Based on this research, we have addressed parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".

## 9. Conclusion

The subject devices and the predicate device have the same intended use and have the same technological characteristics.

Overall, the UNIdental Symphony Implant System has the following similarities to the predicate device:

- * have the same intended use,
- * use the same operating principle,
- * incorporate similar design,
- * incorporate the same material and the sterilization method

Based on the similarities, we conclude that the UNIdental Symphony Implant System is substantially equivalent to the predicate devices.