SD Abutment

K173570 · Surgident Co., Ltd. · NHA · May 17, 2019 · Dental

Device Facts

• Record ID: K173570
• Device Name: SD Abutment
• Applicant: Surgident Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: May 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Indications for Use

SD Abutment is intended for use in partially or fully edentulous maxilla, in support of single or multiple-unit prosthetic restorations. SD Abutment is for single stage and two stage surgical procedures. This system is intended for delayed loading.

Device Story

SD Abutment system comprises dental abutments (healing, solid, dual, dual long, angled, temporary) and screws; interfaces with specific third-party endosseous dental implants. Device fabricated from Ti-6Al-4V ELI (ASTM F136) or Pure Titanium Gr4 (ASTM F67). Used by dental clinicians in clinical settings to support prosthetic restorations. Clinician selects appropriate abutment based on implant platform/body diameter and length; secures to implant fixture. Provides structural support for dental prosthetics; facilitates soft tissue healing or temporary restoration. Benefits patient by enabling functional and aesthetic tooth replacement in edentulous sites.

Clinical Evidence

Bench testing only. Performance data includes 30° compressive loads, fatigue testing, adaptation accuracy, torsional breaking force, and removal torque force, all demonstrating equivalence to predicate devices. Biocompatibility evaluated per ISO 10993-1 (cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, implantation).

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136) and Pure Titanium Gr4 (ASTM F67). Components: Healing, solid, dual, angled (15°, 25°), and temporary abutments with screws. Interface: Internal hex/non-hex. Supplied non-sterile; requires steam sterilization (ISO 17665-1/2).

Indications for Use

Indicated for partially or fully edentulous maxilla and mandible patients requiring single or multiple-unit prosthetic restorations via single or two-stage surgical procedures with delayed loading.

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

• UD Implant System (K131682)

Reference Devices

• s-Clean OneQ-SL Narrow Implant System (K161244)
• OneQ-SL s-Clean Implant System (K153639)

Submission Summary (Full Text)

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May 17, 2019

Surgident Co., Ltd. % Peter Chung Representative Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K173570

Trade/Device Name: SD Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 17, 2019 Received: April 19, 2019

Dear Peter 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 (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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

for Malvina Eydelman, M.D. Director 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) K173570

Device Name SD Abutment

Indications for Use (Describe)

SD Abutment is intended for use in partially or fully edentulous maxilla, in support of single or multipleunit prosthetic restorations. SD Abutment is for single stage and two stage surgical procedures. This system is intended for delayed loading.

The SD Abutment is compatible with the following devices:

| No. | Trade Name | Platform<br>Diameters<br>(mm) | Body<br>Diameters<br>(mm) | Lengths<br>(mm) |
|-----|------------------------------------------|-------------------------------|---------------------------|---------------------|
| 1 | s-Clean OneQ-SL Narrow<br>Implant System | 03.0 | 03.0 | 10, 12, |
| | | 03.3 | 03.3 | 14 |
| 2 | OneQ-SL s-Clean Implant<br>System | 03.7 | 03.5 | |
| | | 03.9 | 03.6 | |
| | | 04.2 | 03.7 | 7, 8, 10,<br>12, 14 |
| | | 04.7 | 04.2 | |
| | | 05.2 | 04.7 | |
| | | 06.0 | 04.8 | 7, 8, 10, |
| | | 07.0 | 05.8 | 12 |
| | | 08.0 | 06.8 | |

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

| <span> <span style="text-decoration:overline">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------------------|
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# K173570 - 510(k) Summary [as required by 807.92(c)]

## 1. Applicant

- a) Company: Surgident Co., Ltd.
- Address: #209~210, Woolim Lion's Valley, 27, Dunchon-daero 457beon-gil, b) Jungwon-gu, Seongnam-si, Gyeonggi-do, 13219, Korea
- [phone] c) Tel :
- d) Fax : [phone]
- e) President of Company: Mr. Duck Su Hur
- f) Contact Person : Peter Chung
- Contact Person Telephone: [phone] g)
- Contact Person Address: 300, Atwood Street, Pittsburgh, PA, 15213, USA h)
- i) Preparation Date: May 17, 2019

#### 2. Device Information

- Trade Name : SD Abutment a)
- Common Name : Endosseous Dental Implant Abutment b)
- Classification Name : c) abutment, implant, dental, endosseous
- d) Product Code : NHA
- e) Regulation Number : 872.3630
- f) Class of device : Class II
- g) Panel : Dental

## 3. Primary Predicate

K131682, UD Implant System / MEDIMECCA Co., Ltd.

#### Reference Device

K161244, s-Clean OneQ-SL Narrow Implant System, Dentis Co., Ltd. K153639, OneQ-SL s-Clean Implant System, Dentis Co., Ltd.

## 4. Device Description and Technological Characteristics

SD Abutment made of Ti-6A1-4V ELI alloy (ASTM F136) and/or Pure Titanium Gr4 (ASTM F67) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, Solid Abutment, Dual Abutment, Dual Long Abutment, Angled Abutment (15° and 25°), Temporary Abutment and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user. The abutments are to be used with the as followed fixtures:

| No. | 510k No. | Trade Name | Platform<br>Diameters<br>(mm) | Body<br>Diameters<br>(mm) | Lengths<br>(mm) | Manufacturer |
|-----|----------|------------------------------------------|-------------------------------|---------------------------|-----------------|---------------------|
| 1 | K161244 | s-Clean OneQ-SL Narrow<br>Implant System | 03.0<br>03.3 | 03.0<br>03.3 | 10, 12,<br>14 | Dentis Co.,<br>Ltd. |
| 2 | K153639 | OneQ-SL s-Clean<br>Implant System | 03.7<br>03.9<br>04.2 | 03.5<br>03.6<br>03.7 | 7, 8, 10, | |

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| | 04.7 | 04.2 12, 14 |
|--|------|----------------|
| | 05.2 | 04.7 |
| | 06.0 | 04.8 7, 8, 10, |
| | 07.0 | 05.8 12 |
| | 08.0 | 06.8 |

#### 5. Indication for Use

SD Abutment is intended for use in partially or fully edentulous mandibles and maxilla, in support of single or multiple-unit prosthetic restorations. SD Abutment is for single stage and two stage surgical procedures. This system is intended for delayed loading.

| No. | Trade Name | Platform<br>Diameters<br>(mm) | Body<br>Diameters<br>(mm) | Lengths<br>(mm) |
|-----|------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|----------------------------------------|
| 1 | s-Clean OneQ-SL Narrow<br>Implant System | 03.0<br>03.3 | 03.0<br>03.3 | 10, 12,<br>14 |
| 2 | OneQ-SL s-Clean Implant<br>System | 03.7<br>03.9<br>04.2<br>04.7<br>05.2<br>06.0<br>07.0<br>08.0 | 03.5<br>03.6<br>03.7<br>04.2<br>04.7<br>04.8<br>05.8<br>06.8 | 7, 8, 10,<br>12, 14<br>7, 8, 10,<br>12 |

# The SD Abutment is compatible with the following devices:

#### 6. Performance Data

- a) Physical Tests

| No. | Test items | Results |
|-----|--------------------------|---------------------------------|
| 1. | 30° Compressive Loads | |
| 2. | Fatigue | |
| 3. | Adaptation Accuracy | |
| 4. | Torsional Breaking Force | |
| 5. | Removal Torque Force | |
| 6. | Adaptation Accuracy | |
| 7. | Torsional Breaking Force | Equivalent to predicate devices |
| 8. | Removal Torque Force | |
| 9. | 30° Compressive Loads | |
| 10. | Fatigue | |
| 11. | Visual | |
| 12. | Dimension | |
| 13. | Package | |

Reverse Engineering tolerance analysis was conducted on the original OEM 3rd party implant body, abutment, and abutment screw to ensure compatibility of the SD Abutment.

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## 7. Predicate Device Comparison Table

The SD Abutment is substantially equivalent to previously marketed devices. The design features and sizing of the components were compared and the SD Abutment found to be substantially equivalent as the predicate device. The primary predicate includes a list of examples for single and multiple unit restorations whereas the subject device contains this information in the labeling for each specific abutment. Additionally, the primary predicate is dental abutments for the predicates own implant bodies whereas the subject device is a 30 party abutment compatible. The inclusion of the specific compatible implant bodies, while different as compared to the primary predicate's Indications for Use, is necessary to adequately identify the indications for the subject device and the appropriate patient population. There are no significant differences between the SD Abutment and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to other devices in design, function, material and intended use.

| | | SUBJECT Device | Primary PREDICATE Device<br>K131682 | | | | | | | | | | | | | | | | | | | | | |
|---------------------|------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | | Surgident Co., Ltd. | MEDIMECCA Co., Ltd. | | | | | | | | | | | | | | | | | | | | | |
| Common Name | | Endosseous Dental Implant<br>Abutment | Endosseous Dental<br>Implant | | | | | | | | | | | | | | | | | | | | | |
| Trade Name | | SD Abutment | UD Implant System | | | | | | | | | | | | | | | | | | | | | |
| Indications for Use | | SD Abutment is intended for use in<br>partially or fully edentulous mandibles and<br>maxilla, in support of single or multiple-<br>unit prosthetic restorations. SD Abutment<br>is for single stage and two stage surgical<br>procedures. This system is intended for<br>delayed loading. The SD Abutment is<br>compatible with the following devices:<br><br>No. 510k No. Trade Name Platform Diameters<br>(mm) Body Diameters<br>(mm) Lengths<br>(mm) Manufacturer 1 K161244 s-Clean OneQ-SL<br>Narrow Implant System 03.0<br>03.3 03.0<br>03.3 10, 12,<br>14 Dentis Co.,<br>Ltd. 2 K153639 OneQ-SL s-Clean<br>Implant System 03.7<br>03.9<br>04.2<br>04.7<br>05.2<br>06.0<br>07.0<br>08.0 03.5<br>03.6<br>03.7<br>04.2<br>04.7<br>04.8<br>05.8<br>06.8 7, 8, 10,<br>12, 14 | | | | | | | | | | | | | | | | | | | | | | UD Implant System<br>intended for use in<br>partially or fully<br>edentulous mandibles and<br>maxilla, in support of<br>single of multiple-unit<br>restorations<br>including: cemented<br>retained, screw retained,<br>or overdenture<br>restorations, and<br>terminal or<br>intermediate abutment<br>support for fixed<br>bridgework. UD<br>Implant System is for<br>single stage and two<br>stage surgical<br>procedures.<br>This<br>system is<br>intended for delayed<br>lading. |
| Components | | Abutments | Fixtures and abutments | | | | | | | | | | | | | | | | | | | | | |
| Healing | Type | Internal | Internal | | | | | | | | | | | | | | | | | | | | | |

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| Abutment | | Diameter (mm) | | | |
|----------------------------|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------------------|--|
| | | 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.5 mm, 8.5 mm | | 4.0 mm, 4.5 mm, 5.5 mm, 6.5 mm | |
| Solid Abutment | Type | Internal | | Internal | |
| | Diameter (mm) | 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm | | 4.0 mm, 4.5 mm, 5.5 mm, 6.5 mm | |
| Dual Abutment | Type | Internal Hex, Internal Non-Hex | | Internal Hex, Internal Non-Hex | |
| | Diameter (mm) | 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm | | 4.0 mm, 4.5 mm, 5.5 mm, 6.5 mm | |
| Dual Long Abutment | Type | Internal Hex, Internal Non-Hex | | Internal Hex, Internal Non-Hex | |
| | Diameter (mm) | 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm | | 4.0 mm, 4.5 mm, 5.5 mm, 6.5 mm | |
| Angled Abutment | Type | Internal Hex, Internal Non-Hex | | Internal Hex, Internal Non-Hex | |
| | Diameter (mm) | 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5mm | | 4.5 mm, 5.5 mm | |
| | Angulation | 15°, 25° | | 15°, 25° | |
| Temporary Abutment | Type | Internal Hex, Internal Non-Hex | | Internal Hex, Internal Non-Hex | |
| | Diameter (mm) | 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm | | 4.0 mm, 4.5 mm | |
| Material | | Ti-6Al-4V ELI (ASTM F136), or Titanium Grade 4 (ASTM F67) | | Ti-6Al-4V ELI (ASTM F136), or Titanium Grade 4 (ASTM F67) | |
| Physical testing performed | | Test according to ISO 14801 | | Test according to ISO 14801 | |
| Biocompatibility | | Biocompatible according to ISO 10993-1 (evaluated cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, implantation) | | Biocompatible according to ISO 10993-1 | |
| Single Use | | yes | | yes | |
| Sterilization method | | The abutment is supplied non-sterile (Steam sterilization prior to use). Validation via ISO 17665-1 & ISO 17665-2 | | Gamma radiation | |

## 8. Conclusion

The SD Abutment is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with "FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments".

The subject device and the predicate device have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of the titanium

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alloys and have not the surface treatments. The subject and the predicate devices encompass the similar range of physical dimensions, including diameter and length of the implants. and diameter of the abutments.

Overall, the SD Abutment has the following similarities to the predicate device:

- . has the same intended use.
- uses the same operating principle. .
- . incorporates the same basic design.
- . incorporates the same material.

Based on the similarities, we conclude that the SD Abutment is substantially equivalent to the predicate device.