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.

Device Description

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.

AI/ML Overview

This document, a 510(k) summary for the SD Abutment, details its substantial equivalence to previously marketed devices. It does not contain information about a study proving the device meets acceptance criteria derived from a performance study involving AI and human readers, nor does it provide a specific table of acceptance criteria with reported device performance.

The document primarily focuses on demonstrating that the SD Abutment is substantially equivalent to predicate devices based on design, materials, and intended use, rather than presenting a novel performance study against specific acceptance criteria. This is typical for a 510(k) submission for dental implant abutments, where the primary regulatory pathway is demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information from the provided text, as the document details a 510(k) submission for a dental implant abutment, not a performance study of a medical device involving AI, human readers, or specific performance metrics like those found in clinical studies for diagnostic or assistive AI tools.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

The SD Abutment is compatible with the following devices:

No.	Trade Name	PlatformDiameters(mm)	BodyDiameters(mm)	Lengths(mm)
1	s-Clean OneQ-SL NarrowImplant System	03.0	03.0	10, 12,
		03.3	03.3	14
2	OneQ-SL s-Clean ImplantSystem	03.7	03.5
		03.9	03.6
		04.2	03.7	7, 8, 10,12, 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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
+82-31-737-2875 c) Tel :
d) Fax : +82-31-737-2876
e) President of Company: Mr. Duck Su Hur
f) Contact Person : Peter Chung
Contact Person Telephone: 412-687-3976 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

No.	510k No.	Trade Name	PlatformDiameters(mm)	BodyDiameters(mm)	Lengths(mm)	Manufacturer
1	K161244	s-Clean OneQ-SL NarrowImplant System	03.003.3	03.003.3	10, 12,14	Dentis Co.,Ltd.
2	K153639	OneQ-SL s-CleanImplant System	03.703.904.2	03.503.603.7	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	PlatformDiameters(mm)	BodyDiameters(mm)	Lengths(mm)
1	s-Clean OneQ-SL NarrowImplant System	03.003.3	03.003.3	10, 12,14
2	OneQ-SL s-Clean ImplantSystem	03.703.904.204.705.206.007.008.0	03.503.603.704.204.704.805.806.8	7, 8, 10,12, 147, 8, 10,12

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 DeviceK131682
Manufacturer		Surgident Co., Ltd.	MEDIMECCA Co., Ltd.
Common Name		Endosseous Dental ImplantAbutment	Endosseous DentalImplant
Trade Name		SD Abutment	UD Implant System
Indications for Use		SD Abutment is intended for use inpartially or fully edentulous mandibles andmaxilla, in support of single or multiple-unit prosthetic restorations. SD Abutmentis for single stage and two stage surgicalprocedures. This system is intended fordelayed loading. The SD Abutment iscompatible with the following devices:No. 510k No. Trade Name Platform Diameters(mm) Body Diameters(mm) Lengths(mm) Manufacturer 1 K161244 s-Clean OneQ-SLNarrow Implant System 03.003.3 03.003.3 10, 12,14 Dentis Co.,Ltd. 2 K153639 OneQ-SL s-CleanImplant System 03.703.904.204.705.206.007.008.0 03.503.603.704.204.704.805.806.8 7, 8, 10,12, 14		UD Implant Systemintended for use inpartially or fullyedentulous mandibles andmaxilla, in support ofsingle of multiple-unitrestorationsincluding: cementedretained, screw retained,or overdenturerestorations, andterminal orintermediate abutmentsupport for fixedbridgework. UDImplant System is forsingle stage and twostage surgicalprocedures.Thissystem isintended for delayedlading.
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.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)