The MagDen Dental Implant System 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, and to restore the patient's chewing function. The MagDen Fixture devices are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. The MagDen Fixture devices are indicated for immediate loading when good primary stability is achieved.

Device Description

The MagDen Dental Implant System offers MagDen Fixture, two abutment types (MagDen Mini Abutment, MagDen Abutment), MagDen Implant Healing Abutment, and MagDen Implant Cover Screw. The MagDen Fixture is made of Titanium alloy (ASTM F136, Ti-6A1-4V ELI) with S.L.A surface treatment. MagDen Mini Abutment and MagDen Abutment are made of Stainless Steel (SUS444) with TiN coating. MagDen Implant Healing Abutment and MagDen Implant Cover Screw are made of titanium alloy (ASTM F136, Ti-6A1-4V ELI) with no surface treatment. The system provides immediate masticatory function for partially and completely edentulous patients.

AI/ML Overview

This document is a 510(k) Premarket Notification for the MagDen Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria and results for an AI/ML device.

Therefore, the requested information, which pertains to the acceptance criteria and study proving device performance (presumably for an AI/ML device, given the detailed questions on ground truth, human readers, and training sets), cannot be extracted from this document.

This document describes a medical device (dental implants) and its intended use, materials, dimensions, and biocompatibility and performance tests, but these are related to the physical properties and safety of the implant itself, and not to the performance of an AI/ML algorithm.

The sections regarding "Acceptance Criteria," "Study," "Sample Sizes," "Ground Truth," "Adjudication," "MRMC," and "Standalone Performance" are not applicable to the content of this 510(k) submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 26, 2017

SHINHUNG MST Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, California 92620

Re: K162867

Trade/Device Name: MagDen Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 28, 2017 Received: June 29, 2017

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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -S

for Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162867

Device Name MagDen Dental Implant System

Indications for Use (Describe)

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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510(K) SUMMARY (K162867)

July 26, 2017

1. Submitted by

SHINHUNG MST Co., Ltd

110-2, Donghwagongdan-ro Munmak-eup, Wonju-si, Gangweon-do, Republic of Korea, 26365 Phone : +82-33-730-1900 Fax : +82-33-730-1919 Contact: Sunbyung, Lee / Manager / Quality assurance team

2. US Agent

Contact: Priscilla Chung (juhee.c@lkconsultinggroup.com) LK Consulting Group USA, Inc. 800 Roosevelt STE 417, Irvine CA 92620

3. Device Name

Trade Name :: MagDen Dental Implant System
· Common Names Dental Implant ・・
· Classification Name Endosseous dental implant (CFR 872.3640) :
DZE (Primary), NHA • Product Codes :

4. Predicate Device

4.1. Primary Predicate Device:
IMTEC Sendax MDI and MDI Plus (K031106) by IMTEC Corporation
4.2. Reference Predicate Device:
- · IMTEC MDI MII One-Piece Implant, 2.9mm (K081653) by IMTEC Corporation
- · IMPLANTIUM PROSTHETICS (K052957) by Dentium Co., Ltd.
- · Anker Dental Implant System SB-III, ST and AT Series (K142557) by Alliance Global Technology Co., Ltd.
- · MAGNA ABUTMENT (K984297) by FACTOR II, INC.

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5. Device Description

The MagDen Dental Implant System offers MagDen Fixture, two abutment types (MagDen Mini Abutment, MagDen Abutment), MagDen Implant Healing Abutment, and MagDen Implant Cover Screw.

The MagDen Fixture provides both partially and completely edentulous patients with immediate masticatory function and it is made of Titanium alloy (ASTM F136, Ti-6A1-4V ELI) and S.L.A (Sand-Blasted, Large Grit, Acid-etched) is applied on the surface. MagDen Mini Abutment and MagDen Abutment are made of Stainless Steel (SUS444) and TiN coating is applied. All of the models of MagDen Mini Abutment and MagDen Abutment are intended for multiple-unit restorations only. MagDen Implant Healing Abutment and MagDen Implant Cover Screw are made of titanium alloy (ASTM F136, Ti-6A1-4V ELI) and no surface treatment for these components.

The size range of the subject fixture is as below.

2.2mm(D)×10.2, 11.7, 13.2, 14.7, 16.2mm(L) ●
. 2.7mm(D)×9.3, 10.0, 10.8, 11.5, 12.3, 13.0, 13.8, 14.5, 15.3, 16.0mm(L)
3.2mm(D)×9.3.10.0. 10.8, 11.5, 12.3, 13.0, 13.8, 14.5, 15.3, 16.0mm(L) ●

The size ranges of the subject abutments are as below.

Cover Screw: 2.676mm(D)×4.4mm(L), 2.56mm(D)×3.7mm(L) ●
. MagDen Mini Abutment: 3.8mm(D)×5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm(L) 4.0mm(D)×4.3, 4.8, 5.3, 5.8, 6.3, 6.8, 7.3, 7.8mm(L) 4.2mm(D)×5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm(L)
. MagDen Abutment: 4.8mm(D)×7.3, 7.8, 8.1, 8.3, 8.4, 8.5, 8.6, 8.8, 9.0, 9.1, 9.3, 9.4, 9.5, 9.6, 9.8, 10.0, 10.1, 10.3, 10.4, 10.5, 10.6, 10.8, 11.0, 11.1, 11.3, 11.4, 11.5, 11.6, 11.8, 12.0, 12.1, 12.3, 12.4, 12.5, 12.6, 12.8, 13.0, 13.1, 13.5, 13.6, 13.6, 13.8, 14.0, 14.1, 14.3, 14.4, 14.5, 14.6, 14.8, 15.0, 15.1, 15.3, 15.4, 15.5, 15.8, 16.0, 16.1, 16.3, 16.4, 16.5, 16.8, 17.0, 17.1, 17.3, 17.4, 17.5, 18.0, 18.4, 18.5, 19.0mm(L)
MagDen Implant Healing Abutment: 4.3mm(D)×5.0, 6.0, 7.0, 8.0, 9.0mm(L)

4.5mm (D)×3.95, 4.8, 5.8, 6.8, 7.8mm(L)

4.7mm (D)×5.0, 6.0, 7.0, 8.0, 9.0mm(L)

6. Indication For Use

7. Substantial Equivalence

The MagDen Dental Implant System is substantially equivalent in intended use, design and performance to the predicated devices. There are slight differences in design but the fundamental technological characteristics between the devices are the same, and also the test results submitted herein support that the subject device is substantially equivalent to the predicate devices.

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The indications for use include description for placement location and implant loading, which do not affect the intended use and are found substantially equivalent to the predicates.

Device Name	Subject Device	Primary PredicateDevice	ReferencePredicate Device
Manufacturer	SHINHUNG MSTCo., Ltd.	IMTEC Corporation	IMTEC Corporation
510(k) Number		K031106	K081653
Device Name	MagDen DentalImplant System	IMTEC Sendax MDIand MDI Plus	IMTEC MDI MIIOne-Piece Implant,2.9mm
Materials	Titanium alloy	Titanium alloy	Titanium alloy
Form	Endosseous dentalimplant	Endosseous dentalimplant	Endosseous dentalimplant
Indications foruse	The MagDen DentalImplant System isintended to besurgically placed inthe bone of the upperor lower jaw arches toprovide support forprosthetic devices,such as artificial teeth,and to restore thepatient's chewingfunction. TheMagDen Fixturedevices arespecifically indicatedfor replacing maxillarylateral incisors andmandibular central andlateral incisors. TheMagDen Fixturedevices are indicatedfor immediate loadingwhen good primarystability is achieved.	The MDI and MDIPLUS are self-tappingtitanium threaded screwsindicated for long-termintra-bony applications.Additionally, the MDImay also be used forinter-radiculartransitional applications.These devices willpermit immediatesplinting stability andlong-term fixation ofnew or existing crownand bridge installations,for full partialendentulism, andemploying minimallyinvasive surgicalintervention.	The M11 Implant isintended to supportsingle or multi-unitrestorations in bothlong-term andtemporary applicationsthroughout the maxillaryand mandibular arches.The MII implant isindicated for immediateloading when goodprimary stability isachieved. Additionally,this device will permitstability and long termfixation of upper andlower dentures inedentulous cases.
Technicalcharacteristics	Screw TypeInternal Type	Screw Type	Screw Type
Sterilization	Sterile(Gamma Radiation)	Sterile	Sterile

7.1. Fixture

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Shape	Image: Dental Implant	Image: Dental Implant	Image: Dental Implant
SurfaceTreatment	S.L.A	S.L.A	S.L.A
Dimension(Diameter,Length)	Ф2.2(D)×10.2, 11.7,13.2, 14.7, 16.2mm(L)Ф2.7(D)×9.3, 10.0,10.8, 11.5, 12.3, 13.0,13.8, 14.5, 15.3,16.0mm(L)Ф3.2(D)×9.3, 10.0,10.8, 11.5, 12.3, 13.0,13.8, 14.5, 15.3,16.0mm(L)	Ф1.8(D)×10.0, 13.0,15.0, 18.0mm(L)Ф2.1(D)×10.0, 13.0,15.0, 18.0mm(L)Ф2.4(D)×10.0, 13.0,15.0, 18.0mm(L)	Ф2.9(D)×10.0, 13.0,15.0, 18.0mm(L)
PlatformDiameter	Ф3.8, Ф4.0	Ф2.7	Ф2.9

7.2. Abutments & Cover Screw

Device Name	Subject Device	Reference PredicateDevice	ReferencePredicate Device	ReferencePredicate Device
Manufacturer	SHINHUNG MSTCo., Ltd.	Dentium Co., Ltd.	Alliance GlobalTechnology Co.,Ltd.	FACTOR II, INC.
510(k) Number	-	K052957	K142557	K984297
Device Name	MagDen DentalImplant System	IMPLANTIUMPROSTHETICS	Anker DentalImplant System -SB-III, ST and ATSeries	MAGNAABUTMENT
Materials	Titanium alloy andstainless steel	Titanium andtitanium alloy	Titanium alloy andstainless steel	Stainless steel
Form	Abutment, Dental,Endosseousimplants	Abutment, Dental,Endosseousimplants	Abutment, Dental,Endosseousimplants	Abutment, Dental,Endosseousimplants

			Anker DentalImplant System isintended to besurgically placed inthe alveolar bone ofupper or lower jawarches to providesupport forprosthetic devices,such as artificialteeth, and to restorethe patient's chewingfunction.Anker DentalImplant System isintended for delayedloading. No matterplacing implants inanterior or posteriorregion, werecommendchoosing thediameter ofimplants as large aspossible. Theprostheticrestorations used aresingle crowns,bridges and partial orfull dentures, whichare connected to theimplants through thecorrespondingcomponents(abutments).Specific indicationsfor small diameter(3.3mm) and short(length <7mm)dental implants:Because of theirreduced mechanicalstability, smalldiameter and shortimplants are onlyused in cases with alow mechanical load.We recommend onlyused in themandibular anterior	Magnacap is amagnetic abutmentfor implant retaineddental andcraniofacialprosthesis and rootsupportedoverdentures.Magnacap isengineered to fitseveralcommerciallyavailable implantfixtures.
Indications foruse	The MagDenDental ImplantSystem is intendedto be surgicallyplaced in the boneof the upper orlower jaw arches toprovide support forprosthetic devices,such as artificialteeth, and torestore thepatient's chewingfunction.	Intended for use as anaid in prostheticrehabilitation.

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		Cover Screw
Shape	Image: screw	Image: screw
Material	Ti-6Al-4V ELI alloy	Ti-6Al-4V ELI alloy
Size	Φ2.676(D)×4.4mm(L)Φ2.56(D)×3.7mm(L)	Dia. 3.50~4.28
		MagDen Mini Abutment	Magna Abutment
Shape	Image: abutment	Image: abutment	Image: abutment
Material	SUS444	Ti-Gr4	Stainless steel
Size	Φ3.8(D)×5.5, 6.0,6.5, 7.0, 7.5, 8.0,8.5, 9.0mm(L)Φ4.0(D)×4.3, 4.8,5.3, 5.8, 6.3, 6.8,7.3, 7.8mm(L)Φ4.2(D)×5.5, 6.0,6.5, 7.0, 7.5, 8.0,8.5, 9.0mm(L)	Dia.4.5~5.5	Φ4.4(D)×3.5, 3.6,5.5mm(L)Φ5.1(D)×2.1, 3.5,5.5mm(L)
		MagDen Abutment
Shape	Image: abutment	Image: abutment
Material	SUS444	Ti-Gr4
Size	Φ4.8(D)×7.3, 7.8,8.1, 8.3, 8.4, 8.5,8.6, 8.8, 9.0, 9.1,9.3, 9.4, 9.5, 9.6,9.8, 10.0, 10.1,10.3, 10.4, 10.5,10.6, 10.8, 11.0,11.1, 11.3, 11.4	Dia.4.5~5.5

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	11.5, 11.6, 11.8,12.0, 12.1, 12.3,12.4, 12.5, 12.6,12.8, 13.0, 13.1,13.3, 13.4, 13.5,13.6, 13.8, 14.0,14.1, 14.3, 14.4,14.5, 14.6, 14.8,15.0, 15.1, 15.3,15.4, 15.5, 15.8,16.0, 16.1, 16.3,16.4, 16.5, 16.8,17.0, 17.1, 17.3,17.4, 17.5, 18.0,18.4, 18.5,19.0mm(L)
MagDen Implant Healing Abutment
Shape	Image: Implant Healing Abutment	Image: Implant Healing Abutment	-
Material	Ti-6Al-4V ELI alloy	Ti-Gr4	-
Size	Φ4.3(D)×5.0, 6.0,7.0, 8.0, 9.0mm(L)Φ4.5×3.95, 4.8,5.8, 6.8, 7.8mm(L)Φ4.7(D)×5.0, 6.0,7.0, 8.0, 9.0mm(L)	Dia.4.5~6.5	-

8. Performance Testing

• Biocompatibility Tests

Biocompatibility testing on the proposed MagDen Dental Implant System has been completed. Requirements for biological evaluation of the proposed device were based on the ISO 7405(2008), "Dentistry-Evaluation of biocompatibility of medical devices used in dentistry." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed.

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No.	Item	Referenced Standard	Results
1	Cytotoxicity	ISO10993-5	No cytotoxicity
2	Genotoxicity	ISO10993-3	No genotoxicity
3	Skin sensitizationreaction	ISO10993-10	No sensitization
4	Intradermal reactivity	ISO10993-10	No intradermal reactivity
5	Acute systemic toxicity	ISO10993-11	No acute systemictoxicity
6	Pyrogenicity	USP37 <151>	No pyrogenicity
7	Transplantation	ISO10993-6	No subchronic toxicity
8	Subchronic toxicity	ISO10993-11	No subchronic toxicity

Fixtures, Healing Abutments, Screws -

Abutments -

No.	Item	Referenced Standard	Results
1	Genotoxicity	ISO10993-3	No genotoxicity
2	Transplantation	ISO10993-6	No subchronic toxicity
3	Subchronic toxicity	ISO10993-11	No subchronic toxicity
4	Delayedhypersensitivity	ISO10993-10	No sensitization
5	Cytotoxicity	ISO10993-5	No cytotoxicity
6	Oral mucosa irritationtest	ISO10993-10	No irritation

● Performance Tests

The proposed devices were evaluated as below to support the substantial equivalence to the predicate devices.

Fixture -

The following performance tests were conducted for the Fixture devices and found to meet the acceptance criteria for demonstrating substantial equivalence: Appearance, Dimensions, Detailed Fitness, and Package integrity.

Abutments
The following performance tests were conducted for the Abutments and found to meet the acceptance criteria for demonstrating substantial equivalence: Appearance, Dimensions, Package integrity, Loosening Torque, Rotational Shear Strength, Retention Force, Detailed Fitness, Surface characteristics, and Galvanic Corrosion.

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. Sterilization Validation Tests
Sterilization validation tests were performed for the fixture and the abutment devices in accordance with the referenced standards below.
Fixtures -
To verify the sterility assurance level (10-6) for gamma sterilization procedure for MagDen Fixtures, the validation and biological indicator (BI) overkill method was used in accordance to ISO 11137-1, 2, 3 and ISO 11737-1, 2, 3.

To verify the sterility assurance level (10-6) for the steam sterilization procedure for MagDen Abutments, the validation and biological indicator (BI) overkill method was used in accordance to ANSVAAMI ST81, ANSVAAMI ST79, ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, AAMI TIR39, AAMI TIR No. 12.

Surface Treatment Evaluations
Bench testing of the SLA modified surface treatment of the fixture devices, and bench testing of the TiN coating modified surface treatment of the abutment devices were performed and the test results support that the surface treatments do not raise a question.
Fixtures
SLA surface cleaning effectiveness tests and surface analysis after the cleaning were performed by various testing methods verified that the chemical agents used to remove particles have been washed from the surface and shows there is no blasting media particles remaining.

Coating porosity, mean volume percent of voids, surface roughness of the coating, and scanning electron microscopy evaluations were performed to evaluate the TiN coating of the subject device, and the test results support that the TiN coating does not raise a question.

9. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, SHINHUNG MST Co., Ltd concludes that the MagDen Dental Implant System is substantially equivalent to the predicate devices as described herein.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.