MagDen Dental Implant System
Device Facts
| Record ID | K162867 |
|---|---|
| Device Name | MagDen Dental Implant System |
| Applicant | Shinhung Mst Co., Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Jul 26, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
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 Story
MagDen Dental Implant System consists of titanium alloy (ASTM F136) fixtures with S.L.A. surface treatment, stainless steel (SUS444) abutments with TiN coating, healing abutments, and cover screws. System provides support for prosthetic devices (artificial teeth) to restore chewing function in edentulous patients. Surgically placed in maxillary or mandibular bone by dental professionals. Fixtures support immediate loading if primary stability is achieved. Abutments intended for multiple-unit restorations. Device provides mechanical foundation for dental prosthetics; benefits include restoration of masticatory function and oral aesthetics.
Clinical Evidence
Bench testing only. No clinical data provided. Biocompatibility testing performed per ISO 10993 series (cytotoxicity, genotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity). Mechanical performance testing included loosening torque, rotational shear strength, retention force, and galvanic corrosion. Sterilization validation performed per ISO 11137 (gamma) and ISO 17665 (steam) to achieve 10^-6 SAL.
Technological Characteristics
Materials: Titanium alloy (ASTM F136, Ti-6Al-4V ELI) and Stainless Steel (SUS444). Surface: S.L.A. (Sand-Blasted, Large Grit, Acid-etched) on fixtures; TiN coating on abutments. Energy: None (mechanical). Sterilization: Gamma radiation (fixtures) and steam (abutments). Form factor: Screw-type endosseous dental implant system with various diameters and lengths.
Indications for Use
Indicated for patients requiring prosthetic support for artificial teeth in the upper or lower jaw arches, specifically for replacing maxillary lateral incisors and mandibular central and lateral incisors. Indicated for immediate loading when good primary stability is achieved.
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
- IMTEC Sendax MDI and MDI Plus (K031106)
Reference Devices
- IMTEC MDI MII One-Piece Implant, 2.9mm (K081653)
- IMPLANTIUM PROSTHETICS (K052957)
- Anker Dental Implant System SB-III, ST and AT Series (K142557)
- MAGNA ABUTMENT (K984297)
Related Devices
- K202039 — Honorst Implant System · Medimecca Co., Ltd. · Sep 25, 2020
- K231429 — S-Plant Dental Implant System · Idis Co., Ltd. · Dec 18, 2023
- K232268 — STERI-OSS Implant System · Zeros Co., Ltd. · Mar 25, 2024
- K112440 — AB DENTAL DEVICES IMPLANTS AND ACCESSORIES · A.B. Dental Devices , Ltd. · Apr 18, 2012
- K240383 — Highness Implant System · Highness Co., Ltd. · Oct 31, 2024
Submission Summary (Full Text)
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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)
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.
| 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
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.
### 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 Predicate<br>Device | Reference<br>Predicate Device |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SHINHUNG MST<br>Co., Ltd. | IMTEC Corporation | IMTEC Corporation |
| 510(k) Number | | K031106 | K081653 |
| Device Name | MagDen Dental<br>Implant System | IMTEC Sendax MDI<br>and MDI Plus | IMTEC MDI MII<br>One-Piece Implant,<br>2.9mm |
| Materials | Titanium alloy | Titanium alloy | Titanium alloy |
| Form | Endosseous dental<br>implant | Endosseous dental<br>implant | Endosseous dental<br>implant |
| Indications for<br>use | The MagDen Dental<br>Implant System is<br>intended to be<br>surgically placed in<br>the bone of the upper<br>or lower jaw arches to<br>provide support for<br>prosthetic devices,<br>such as artificial teeth,<br>and to restore the<br>patient's chewing<br>function. The<br>MagDen Fixture<br>devices are<br>specifically indicated<br>for replacing maxillary<br>lateral incisors and<br>mandibular central and<br>lateral incisors. The<br>MagDen Fixture<br>devices are indicated<br>for immediate loading<br>when good primary<br>stability is achieved. | The MDI and MDI<br>PLUS are self-tapping<br>titanium threaded screws<br>indicated for long-term<br>intra-bony applications.<br>Additionally, the MDI<br>may also be used for<br>inter-radicular<br>transitional applications.<br>These devices will<br>permit immediate<br>splinting stability and<br>long-term fixation of<br>new or existing crown<br>and bridge installations,<br>for full partial<br>endentulism, and<br>employing minimally<br>invasive surgical<br>intervention. | The M11 Implant is<br>intended to support<br>single or multi-unit<br>restorations in both<br>long-term and<br>temporary applications<br>throughout the maxillary<br>and mandibular arches.<br>The MII implant is<br>indicated for immediate<br>loading when good<br>primary stability is<br>achieved. Additionally,<br>this device will permit<br>stability and long term<br>fixation of upper and<br>lower dentures in<br>edentulous cases. |
| Technical<br>characteristics | Screw Type<br>Internal Type | Screw Type | Screw Type |
| Sterilization | Sterile<br>(Gamma Radiation) | Sterile | Sterile |
# 7.1. Fixture
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| Shape | Image: Dental Implant | Image: Dental Implant | Image: Dental Implant |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Surface<br>Treatment | S.L.A | S.L.A | S.L.A |
| Dimension<br>(Diameter,<br>Length) | Ф2.2(D)×10.2, 11.7,<br>13.2, 14.7, 16.2mm(L)<br>Ф2.7(D)×9.3, 10.0,<br>10.8, 11.5, 12.3, 13.0,<br>13.8, 14.5, 15.3,<br>16.0mm(L)<br>Ф3.2(D)×9.3, 10.0,<br>10.8, 11.5, 12.3, 13.0,<br>13.8, 14.5, 15.3,<br>16.0mm(L) | Ф1.8(D)×10.0, 13.0,<br>15.0, 18.0mm(L)<br>Ф2.1(D)×10.0, 13.0,<br>15.0, 18.0mm(L)<br>Ф2.4(D)×10.0, 13.0,<br>15.0, 18.0mm(L) | Ф2.9(D)×10.0, 13.0,<br>15.0, 18.0mm(L) |
| Platform<br>Diameter | Ф3.8, Ф4.0 | Ф2.7 | Ф2.9 |
# 7.2. Abutments & Cover Screw
| Device Name | Subject Device | Reference Predicate<br>Device | Reference<br>Predicate Device | Reference<br>Predicate Device |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SHINHUNG MST<br>Co., Ltd. | Dentium Co., Ltd. | Alliance Global<br>Technology Co.,<br>Ltd. | FACTOR II, INC. |
| 510(k) Number | - | K052957 | K142557 | K984297 |
| Device Name | MagDen Dental<br>Implant System | IMPLANTIUM<br>PROSTHETICS | Anker Dental<br>Implant System -<br>SB-III, ST and AT<br>Series | MAGNA<br>ABUTMENT |
| Materials | Titanium alloy and<br>stainless steel | Titanium and<br>titanium alloy | Titanium alloy and<br>stainless steel | Stainless steel |
| Form | Abutment, Dental,<br>Endosseous<br>implants | Abutment, Dental,<br>Endosseous<br>implants | Abutment, Dental,<br>Endosseous<br>implants | Abutment, Dental,<br>Endosseous<br>implants |
| | | | | |
| | | | Anker Dental<br>Implant System is<br>intended to be<br>surgically placed in<br>the alveolar bone of<br>upper or lower jaw<br>arches to provide<br>support for<br>prosthetic devices,<br>such as artificial<br>teeth, and to restore<br>the patient's chewing<br>function.<br><br>Anker Dental<br>Implant System is<br>intended for delayed<br>loading. No matter<br>placing implants in<br>anterior or posterior<br>region, we<br>recommend<br>choosing the<br>diameter of<br>implants as large as<br>possible. The<br>prosthetic<br>restorations used are<br>single crowns,<br>bridges and partial or<br>full dentures, which<br>are connected to the<br>implants through the<br>corresponding<br>components<br>(abutments).<br>Specific indications<br>for small diameter<br>(3.3mm) and short<br>(length <7mm)<br>dental implants:<br>Because of their<br>reduced mechanical<br>stability, small<br>diameter and short<br>implants are only<br>used in cases with a<br>low mechanical load.<br>We recommend only<br>used in the<br>mandibular anterior | Magnacap is a<br>magnetic abutment<br>for implant retained<br>dental and<br>craniofacial<br>prosthesis and root<br>supported<br>overdentures.<br><br>Magnacap is<br>engineered to fit<br>several<br>commercially<br>available implant<br>fixtures. |
| Indications for<br>use | The MagDen<br>Dental Implant<br>System is intended<br>to be surgically<br>placed in the bone<br>of the upper or<br>lower jaw arches to<br>provide support for<br>prosthetic devices,<br>such as artificial<br>teeth, and to<br>restore the<br>patient's chewing<br>function. | Intended for use as an<br>aid in prosthetic<br>rehabilitation. | | |
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| | | | lateral incisor. | | |
|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------------------|----------------------------------------------------------------|--|
| | | | | | |
| | | | | | |
| | | 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)<br>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,<br>6.5, 7.0, 7.5, 8.0,<br>8.5, 9.0mm(L)<br>Φ4.0(D)×4.3, 4.8,<br>5.3, 5.8, 6.3, 6.8,<br>7.3, 7.8mm(L)<br>Φ4.2(D)×5.5, 6.0,<br>6.5, 7.0, 7.5, 8.0,<br>8.5, 9.0mm(L) | Dia.4.5~5.5 | | Φ4.4(D)×3.5, 3.6,<br>5.5mm(L)<br>Φ5.1(D)×2.1, 3.5,<br>5.5mm(L) | |
| | | MagDen Abutment | | | |
| Shape | Image: abutment | Image: abutment | | | |
| Material | SUS444 | Ti-Gr4 | | | |
| Size | Φ4.8(D)×7.3, 7.8,<br>8.1, 8.3, 8.4, 8.5,<br>8.6, 8.8, 9.0, 9.1,<br>9.3, 9.4, 9.5, 9.6,<br>9.8, 10.0, 10.1,<br>10.3, 10.4, 10.5,<br>10.6, 10.8, 11.0,<br>11.1, 11.3, 11.4 | Dia.4.5~5.5 | | | |
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| | 11.5, 11.6, 11.8,<br>12.0, 12.1, 12.3,<br>12.4, 12.5, 12.6,<br>12.8, 13.0, 13.1,<br>13.3, 13.4, 13.5,<br>13.6, 13.8, 14.0,<br>14.1, 14.3, 14.4,<br>14.5, 14.6, 14.8,<br>15.0, 15.1, 15.3,<br>15.4, 15.5, 15.8,<br>16.0, 16.1, 16.3,<br>16.4, 16.5, 16.8,<br>17.0, 17.1, 17.3,<br>17.4, 17.5, 18.0,<br>18.4, 18.5,<br>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,<br>7.0, 8.0, 9.0mm(L)<br>Φ4.5×3.95, 4.8,<br>5.8, 6.8, 7.8mm(L)<br>Φ4.7(D)×5.0, 6.0,<br>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 sensitization<br>reaction | ISO10993-10 | No sensitization |
| 4 | Intradermal reactivity | ISO10993-10 | No intradermal reactivity |
| 5 | Acute systemic toxicity | ISO10993-11 | No acute systemic<br>toxicity |
| 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 | Delayed<br>hypersensitivity | ISO10993-10 | No sensitization |
| 5 | Cytotoxicity | ISO10993-5 | No cytotoxicity |
| 6 | Oral mucosa irritation<br>test | 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.
