IU Implant System

K172345 · Warantec Co., Ltd. · DZE · Jun 18, 2018 · Dental

Device Facts

• Record ID: K172345
• Device Name: IU Implant System
• Applicant: Warantec Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jun 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IU 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.

Device Story

IU Implant System consists of endosseous dental implants (fixtures) and various abutments; fixtures surgically placed in upper or lower jaw bone to support prosthetic devices; restores patient chewing function. Fixtures available in triangular or square screw thread designs; made of pure titanium (ASTM F67); surface treated via sandblasting and acid etching (SLA). Abutments made of titanium alloy (ASTM F136). System used by dental professionals in clinical settings. Fixtures supplied sterile (gamma radiation); abutments supplied non-sterile (require steam sterilization). Output is a stable foundation for dental prostheses; clinical decision-making based on anatomical situation and prosthetic needs. Benefits include restoration of oral function and support for artificial teeth.

Clinical Evidence

No clinical data were included in this submission. Evidence is based on non-clinical bench testing, including biocompatibility (ISO 10993-1, ISO 7405), sterilization validation (ISO 11137, ISO 17665), shelf-life testing (ASTM F1980), and risk analysis (ISO 14971).

Technological Characteristics

Endosseous root-form dental implants. Materials: Pure titanium (ASTM F67) for fixtures; titanium alloy (ASTM F136) for abutments. Surface: Sandblasted and acid-etched (SLA). Connection: Internal hex. Sterilization: Gamma radiation (fixtures), steam sterilization (abutments). Dimensions: Various diameters and lengths provided. No software or electronic components.

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw arches to support prosthetic devices (e.g., artificial teeth) and restore chewing function.

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

• Luna Dental Implant System (K123155)

Reference Devices

• SuperLine (K160965)
• AnyOne 100 Internal Implant System (K123988)
• Dentium Implantium & SuperLine Prosthetics (K141457)
• Dentium Implantium & SuperLine Prosthetics (K160828)

Submission Summary (Full Text)

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WARANTEC Company, Limited % Peter Chung Representative Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K172345

Trade/Device Name: IU Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 21, 2018 Received: May 24, 2018

#### 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. 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.

June 18, 2018

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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); good manufacturing practice requirements as set forth in 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.

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,

Mary S. Runner -S

For Tina Kiang, Ph.D. 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K172345

Device Name IU Implant System

#### Indications for Use (Describe)

The IU 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.

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

# I. SUBMITTER

- a) Company: WARANTEC Co., Ltd.
- b) Address: #411, #412, 474, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13229, Korea
- Tel : [phone] c)
- Fax : [phone] d)
- President of Company: Mr. Dong-Hwa Jang e)
- f) Contact Person : Peter Chung, 412-687-3976
- Contact Person Address: 300, Atwood Street, Pittsburgh, PA, 15213, USA g)
- Date Prepared: June 16, 2018 h)

# II. DEVICE

- IU Implant System a) Trade Name :
- Common Name : Endosseous Dental Implant System b)
- c) Classification Name : implant, endosseous, root-form
- Product Code : DZE (primary), NHA (secondary) d)
- Regulation Number : 872.3640 e)
- f) Class of device : Class II
- Panel : Dental g)

## III.PREDICATE DEVICE

- Primary Predicate Device: a) Luna Dental Implant System / SHINHUNG MST Co., Ltd. / K123155
- Reference Device: b) SuperLine / DENTIUM CO., LTD. / K160965 AnyOne 100 Internal Implant System / MegaGenImplant Co., Ltd. / K123988 Dentium Implantium® & SuperLine® Prosthetics / DENTIUM CO., LTD. / K141457 Dentium Implantium & SuperLine Prosthetics / DENTIUM CO., LTD. / K160828

## IV. DEVICE DESCRIPTION

The IU Implant System is an integrated system of endosseous dental implants with corresponding various abutments (cover screw, two piece abutment, solid abutment, abutment screw, ball abutment, retained abutment, temporary abutment, and multi abutment).

The IU Implant System is a dental implant made of titanium metal intended to be

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surgically placed in the bone of the upper or lower jaw arches.

There are two types of Fixtures, triangular screw threads design and square screw threads design. The IU Implant System includes the each fixtures is available in various diameters (lengths) 3.6 mm (8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 4.1 mm, 4.6 mm, 5.1 mm, 5.6 mm, 6.1 mm (7.5 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) of triangular screw threads design and 4.3 mm, 4.8 mm, 5.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 6.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm) of square screw threads design according to the anatomical situation. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.

Abutment is device made of titanium alloy and it is intended for use to make permanent prostheses and/or temporary prosthesis. The abutments are provided non-sterile and should be sterilized before use.

#### V. INDICATIONS FOR USE

The IU 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.

#### VI. SUBSTANIAL EQUIVALNECE COMPARISON

The IU Implant System is similar designs and dimensions, and has the same material, intended use, surface treatment and technological characteristics as the identified primary predicate device (K123155) and reference devices (K160965/K123988/ K141457). When compared with predicate device, no new questions of substantial equivalence have been raised for the IU Implant System.

| | Subject Device | Primary Predicate<br>Device | Reference Device | Reference Device |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| 510(k) Number | K172345 | K123155 | K160965 | K123988 |
| Manufacturer | WARANTEC Co., Ltd. | SHINHUNG MST Co., Ltd. | DENTIUM CO., LTD. | MegaGenImplant Co., Ltd. |
| Common Name | Endosseous Dental Implant System | Endosseous Dental Implant System | Endosseous Dental Implant System | Endosseous Dental Implant System |
| Trade Name | IU Implant System | Luna Dental Implant System | SuperLine | AnyOneTM Internal Implant System |
| Device class | Class II | Class II | Class II | Class II |
| Product Code(s) | DZE | DZE | DZE | DZE |
| Indications for Use/<br>Intended Use | The IU Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to | The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or | SuperLine is indicated for use in surgical and restorative applications for placement in the bone of the upper or | The AnyOneTM Internal Implant System is intended to be surgically placed in the maxillary or |
| | provide support for | lower jaw arches to | lower jaw to provide | mandibular molar |
| | prosthetic devices, | provide support for | support for prosthetic | areas for the purpose |
| | such as artificial teeth, | prosthetic devices, | devices, such as | providing prosthetic |
| | and to restore the | such as artificial teeth, | artificial teeth, in order | support for dental |
| | patient's chewing | and to restore the | to restore the patient's | restorations (Crown, |
| | function. | patient's chewing | chewing function. | bridges, and |
| | | function. | SuperLine is indicated | overdentures) in |
| | | | also for immediate | partially or fully |
| | | | loading when good | edentulous individuals. |
| | | | primary stability is | It is used to restore a |
| | | | achieved and with | patient's chewing |
| | | | appropriate occlusal | function. Smaller |
| | | | loading. | implants (less than |
| | | | | 06.0 mm) are |
| | | | | dedicated for |
| | | | | immediate loading |
| | | | | when good primary |
| | | | | stability is achieved |
| | | | | and with appropriate |
| | | | | occlusal loading. |
| | | | | Larger implants are |
| | | | | dedicated for the molar |
| | | | | region and are |
| | | | | indicated for delayed |
| | | | | loading. |
| Implant design | Root-form endosseous | Implant, Endosseous, | Root-form endosseous | Root-form endosseous |
| | dental implants | Root-Form | dental implants | dental implants |
| Shape | a)<br>b) | | | |
| Connection | 2.1, 2.5 Internal Hex | 2.1, 2.5 Internal Hex | Internal Hex | Internal Hex |
| Diameter of fixture | a) 3.6, 4.1, 4.6, 5.1, | 3.7, 4.2 – 5.7 mm | 3.6, 4.0, 4.4, 4.9, 6.0, | Internal type |
| | 5.6, 6.1 mm | | 7.0 mm | 3.9, 4.3, 5.3, 6.3, 7.3 |
| | b) 4.3, 4.8, 5.3, 6.3 | | | mm (for normal |
| | mm | | | thread) |
| | | | | 4.8, 5.8, 6.8, 7.8, 8.3 |
| | | | | mm (for deep thread) |
| | | | | 4.8, 5.3, 6.3, 7.3 mm |
| | | | | (for special length) |
| Length of fixture | a) 7.5, 8.5, 10.0, 11.5, | 8.5 — 15.0 mm | 7.0, 8.0, 10.0, 12.0, | Internal type |
| | 13.0 mm | | 14.0 mm | 7.0, 8.0, 9.5, 11.0, |
| | (cf. 3.6 mm diameter | | | 12.5, 14.5 mm (for |
| | does not include a 7.5 | | | normal and deep |
| | mm length.) | | | thread) |
| | b) 7.0, 8.5, 10.0, 11.5, | | | 7.0 mm (for special |
| | 13.0 mm | | | length) |
| | (cf. 6.3 mm diameter | | | |
| | does not include a 13.0 | | | |
| | mm length.) | | | |
| Material | Pure titanium (ASTM<br>F67) | Pure titanium (ASTM<br>F67) | Pure titanium (ASTM<br>F67) | Pure titanium (ASTM<br>F67) |
| Physical testing<br>performed | Not tested/no<br>angulation submitted<br>for clearance. | Test according to ISO<br>14801 | Test according to ISO<br>14801 | Test according to ISO<br>14801 |
| Biocompatibility | Biocompatible<br>according to ISO<br>10993-1 | Biocompatible<br>according to ISO<br>10993-1 | Biocompatible<br>according to ISO<br>10993-1 | Biocompatible<br>according to ISO<br>10993-1 |
| Surface treatment | S.L.A | S.L.A | S.L.A | S.L.A |
| Sterilization method | Gamma radiation | Gamma radiation | Gamma radiation | Gamma sterilization |
| Shelf-life | 7years | - | 8years | - |

Table 1 - Comparison of Endosseous Implant Characteristics

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# Table 2 - Comparison of Endosseous Abutments Characteristics

| | Subject Device | Primary Predicate<br>Device | Reference Device | Reference Device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K172345 | K123155 | K141457 | K123988 |
| Manufacturer | WARANTEC Co., Ltd. | SHINHUNG MST<br>Co., Ltd. | DENTIUM CO., LTD. | MegaGenImplant Co.,<br>Ltd. |
| Common Name | Endosseous Dental<br>Implant System | Endosseous Dental<br>Implant System | Endosseous Dental<br>Implant System | Endosseous Dental<br>Implant System |
| Trade Name | IU Implant System | Luna Dental Implant<br>System | Dentium Implantium®<br>& SuperLine®<br>Prosthetics | AnyOne™ Internal<br>Implant System |
| Device class | Class II | Class II | Class II | Class II |
| Product Code(s) | NHA | NHA | NHA | NHA |
| Indications for Use | The IU Implant<br>System is intended to<br>be 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 Luna Dental<br>Implant System is<br>intended to be<br>surgically placed in the<br>bone of the upper or<br>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. | Dentium Implantium®<br>& SuperLine®<br>Prosthetics are<br>intended for use as an<br>aid in prosthetic<br>rehabilitation. | The AnyOne ™<br>Internal Implant<br>System is intended to<br>be surgically placed in<br>the maxillary or<br>mandibular molar<br>areas for the purpose<br>providing prosthetic<br>support for dental<br>restorations (Crown,<br>bridges, and<br>overdentures) in<br>partially or fully<br>edentulous individuals.<br>It is used to restore a<br>patient's chewing<br>function. Smaller |

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| | Subject Device | Primary Predicate<br>Device | Reference Device | Reference Device |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K172345 | K123155 | K141457 | K123988<br>implants (less than<br>06.0 mm) are<br>dedicated for<br>immediate loading<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading.<br>Larger implants are<br>dedicated for the molar<br>region and are<br>indicated for delayed<br>loading. |
| Cover Screw | | | | |
| Shape | Image: Cover Screw Shape 1 | Image: Cover Screw Shape 2 | Image: Cover Screw Shape 3 | Image: Cover Screw Shape 4 |
| Material | Pure titanium (ASTM<br>F67) | Pure titanium (ASTM<br>F67) | Ti-6Al-4V-ELI<br>(ASTM F136) | CP4 Titanium (ASTM<br>F67) |
| Diameter | 2.82, 3.32 mm | - | 3.6 mm | - |
| Abutment Screw | | | | |
| Shape | Image: Abutment Screw Shape 1 | Image: Abutment Screw Shape 2 | Image: Abutment Screw Shape 3 | Image: Abutment Screw Shape 4 |
| Material | Titanium alloy (ASTM<br>F136) | Titanium alloy (ASTM<br>F136) | Titanium alloy (ASTM<br>F136) | Ti-6Al-4V-ELI |
| Diameter | 2.2 mm | - | 1.8 ~ 2.3 mm | 3.8 ~ 10.0 mm |
| | Subject Device | Primary Predicate<br>Device | Reference Device | Reference Device |
| 510(k) Number | K172345 | K123155 | K160828 | K123988 |
| Manufacturer | WARANTEC Co., Ltd. | SHINHUNG MST<br>Co., Ltd. | DENTIUM CO., LTD. | MegaGenImplant Co.,<br>Ltd. |
| Common Name | Endosseous Dental<br>Implant System | Endosseous Dental<br>Implant System | Endosseous Dental<br>Implant System | Endosseous Dental<br>Implant System |
| Trade Name | IU Implant System | Luna Dental Implant<br>System | Dentium Implantium®<br>& SuperLine®<br>Prosthetics | AnyOneTM Internal<br>Implant System |
| Device class | Class II | Class II | Class II | Class II |
| Product Code(s) | NHA | NHA | NHA | NHA |
| Indications for Use | The IU Implant<br>System is intended to<br>be surgically placed in | The Luna Dental<br>Implant System is<br>intended to be | Dentium Implantium®<br>& SuperLine®<br>Prosthetics are | The AnyOne TM<br>Internal Implant<br>System is intended to |
| | Subject Device | Primary Predicate<br>Device | Reference Device | Reference Device |
| 510(k) Number | K172345 | K123155 | K160828 | K123988 |
| | 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. | surgically placed in the<br>bone of the upper or<br>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. | intended for use as an<br>aid in prosthetic<br>rehabilitation. | be surgically placed in<br>the maxillary or<br>mandibular molar<br>areas for the purpose<br>providing prosthetic<br>support for dental<br>restorations (Crown,<br>bridges, and<br>overdentures) in<br>partially or fully<br>edentulous individuals.<br>It is used to restore a<br>patient's chewing<br>function. Smaller<br>implants (less than<br>06.0 mm) are<br>dedicated for<br>immediate loading<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading.<br>Larger implants are<br>dedicated for the molar<br>region and are<br>indicated for delayed<br>loading. |
| Temporary Abutment | | | | |
| Shape | Image: (Hex) (Non-Hex) | Image: (Hex) (Non-Hex) | Image: (Hex) (Non-Hex) | Image: Ti-6A1-4V-ELI |
| Material | Titanium alloy (ASTM<br>F136) | Titanium alloy (ASTM<br>F136) | Pure Titanium Grade 5<br>(ASTM F67) | Ti-6A1-4V-ELI |
| Diameter | 3.9 mm | 4.0 ~ 6.0 mm | 4.5 mm | 3.8 ~ 10.0 mm |
| Two Piece Abutment | | | | |
| Shape | Image: (Hex) | Image: (Hex) (Non-Hex) | Image: (Hex) (Non-Hex) | Image: (Hex) (Non-Hex) |
| | Subject Device | Primary Predicate<br>Device | Reference Device | Reference Device |
| 510(k) Number | K172345 | K123155 | K160828 | K123988 |
| | (Hex) (Non-Hex) | | |…