Highness Implant System

K240383 · Highness Co., Ltd. · DZE · Oct 31, 2024 · Dental

Device Facts

• Record ID: K240383
• Device Name: Highness Implant System
• Applicant: Highness Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Oct 31, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Highness Implant System is designed to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (crowns, bridges, and overdentures) in partially or fully edentulous individuals. It is used to the restore the patient's chewing function. Implants with diameter less than ø5.5mm are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated to the molar region and are indicated for delayed loading. The Multi-Unit Abutments are intended for multi-unit restorations only and can be used up to 25 degrees when connecting cylinder.

Device Story

Highness Implant System consists of titanium fixtures and abutments for dental prosthetic support. Fixtures are surgically placed in maxillary or mandibular bone to restore chewing function. Fixtures feature SLA surface treatment. Abutments (cemented, angled, solid, temporary, multi-unit) connect to fixtures via screws to support crowns, bridges, or overdentures. System used by dentists/oral surgeons in clinical settings. Fixtures supplied sterile (gamma); abutments supplied non-sterile for user steam sterilization. Output is a stable foundation for dental restorations. Benefits include restoration of chewing function and oral aesthetics.

Clinical Evidence

No clinical data. Evidence is bench-only, including dynamic fatigue testing per ISO 14801:2016 (5,000,000 cycles), surface characterization (SEM/EDS), biocompatibility testing per ISO 10993-1/5/7405, sterilization validation (gamma and steam), sterile barrier shelf-life testing (ASTM F1980-21), and MRI safety assessment via scientific rationale.

Technological Characteristics

Fixtures: CP Titanium Grade 4, SLA surface (hydroxyapatite/tricalcium phosphate abrasive). Abutments/Screws: Ti-6Al-4V ELI (ASTM F136). Connection: Internal Hex/Non-hex/Conical. Sterilization: Gamma (fixtures), Steam (abutments). Shelf life: 5 years. No software/electronics.

Indications for Use

Indicated for partially or fully edentulous individuals requiring prosthetic support for dental restorations (crowns, bridges, overdentures) in maxillary or mandibular arches. Implants <ø5.5mm indicated for immediate loading (if primary stability achieved); larger implants indicated for delayed loading in molar regions. Multi-unit abutments indicated for multi-unit restorations only.

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

• AnyRidge Octa 1 Implant System (K182448)

Reference Devices

• AnyOne ™ Internal Implant System (K123988)
• Solid Abutment for ST Internal Implant System (K192347)
• Multi-unit Abutment For Multi-unit Abutment, Multi-unit Angled Abutment (K203808)
• Healing Abutment for AnyRidge Internal System (K110955)
• Link Abutment for CEREC (K160519)

Submission Summary (Full Text)

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October 31, 2024

highness Co., Ltd. % Sanghwa Myung Regulatory Affair Specialist E&m D1474, PyeongCheon Arco Tower, 230, Simin-Daro, Dongan-gu Anvangsi. Gyeonggido 14067 KOREA, SOUTH

Re: K240383

Trade/Device Name: Highness Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 8, 2024 Received: October 3, 2024

Dear Sanghwa Myung:

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 (the 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 available 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Sherrill Lathrop Blitzer

for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices 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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DEPARTMENT0 OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

K240383

Device Name

Highness Implant System

Indications for Use (Describe)

The Highness Implant System is designed to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (crowns, bridges, and overdentures) in partially or fully edentulous individuals. It is used to the restore the patient's chewing function. Implants with diameter less than ø5.5mm are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated to the molar region and are indicated for delayed loading.

The Multi-Unit Abutments are intended for multi-unit restorations only and can be used up to 25 degrees when connecting cylinder.

| 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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#### K240383

#### 510(k) Summary

#### For

#### Highness Implant System

[Complying with 21 CFR 807.92]

#### SUBMISSION SPONSOR l.

highness Co., Ltd.

98-10, Hyeondae-ro, Waegwan-eup, Chilgok-gun, Gyeongsangbuk-do, Republic of Korea Office Phone: [phone] Fax: [phone] Contact Person: Ms. Ji-yun Jeong, RA Manager

#### II. SUBMISSION CORRESPONDENT

E&M

D1474, PyeongCheon Arco Tower, 230, Simin-Daro, Dongan-gu, Anyangsi, 14067, Republic of Korea Cell Phone: [phone] Office Phone: [phone] Contact: Ms. Sang-hwa Myung, Regulatory Affair Specialist Email: [e-mail]

#### III. DATE PREPARED

October 31, 2024

#### IV. DEVICE

| Trade or Proprietary Name: | Highness Implant System |
|----------------------------|---------------------------------------------|
| Common or Usual Name: | Endosseous Dental Implant |
| Classification Name: | Endosseous dental implant (21 CFR 872.3640) |
| Regulatory Class: | II |
| Product Code: | DZE, NHA |
| Classification Panel: | Dental |

#### V. PRIMARY PREDICATE AND REFERENCE DEVICES

Primary Predicate Device: K182448, AnyRidge Octa 1 Implant System/ MegaGen Implant Co., Ltd.

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Reference Devices:

K123988, AnyOne ™ Internal Implant System / MegaGen Implant Co., Ltd.

K192347, Solid Abutment for ST Internal Implant System / Megagen Implant Co. Ltd.

K203808, Multi-unit Abutment For Multi-unit Abutment, Multi-unit Angled Abutment / Megagen Implant Co. Ltd.

K110955, Healing Abutment for AnyRidge Internal System / Megagen Implant Co. Ltd. K160519, Link Abutment for CEREC / OSSTEM Implant Co., Ltd.

#### VI. DEVICE DESCRIPTION

The Highness Implant System is a titanium-metal dental implant designed to be surgically placed in the bone of the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The Highness Implant System consists of fixtures and abutments.

The fixture is made of pure titanium metal and is supplied sterile (gamma irradiated). The surface is SLA, sandblasted (using 425-180-micron MCD apatitic abrasive, which is a granular, multi-phase calcium phosphate composed primarily of hydroxyapatite and tricalcium phosphate), large grit, acid-etched (solution of hydrochloric acid and nitric acid), treated.

The dimensional range of the fixture is as follows:

| Fixture | Diameter (ø) | Length (mm) |
|---------|------------------------------|------------------------------|
| HS-I | 4.2, 4.6, 5.1, 5.6, 6.0, 7.0 | 7.0, 8.5, 10, 11.5, 13, 14.5 |
| HS-VII | 4.2, 4.7, 5.2, 5.7, 6.2, 7.0 | 7.0, 8.5, 10, 11.5, 13, 14.5 |

The abutments are made of Ti-6Al-4V ELI titanium alloy (ASTM F136). It consists of a Cemented Abutment, Angled Abutment, Solid Abutment, Temporary Abutment, and Multi-Unit Abutment Screw & Abutment Screw, which are intended for use as an aid in single- or multiple-unit prosthetic restorations, and the Multi-Unit Abutment and Multi-Angled Abutment, which are intended for use only as aids in multiple-unit prosthetic restorations. In addition, Cover Screws and Healing Abutments are prefabricated prosthetic components that connect directly to endosseous dental implants and are indicated as temporary components to allow for soft tissue healing. All abutments are supplied non-sterile and individually packaged in FDA cleared wraps and/or pouches. The abutments should be sterilized prior to use by the end-user. And temporary abutments are intended to be used 6 months.

The abutments are compatible with both HS - I and HS - VII implant bodies.

| Abutment | Diameter (ø) | Post Height (mm) | Cuff Height (mm) | Angulation (°) | Surface |
|-------------------|-------------------------|------------------|------------------------------|----------------|----------|
| Cemented Abutment | 4.5, 5.0, 5.5, 6.0, 6.5 | 4.0, 5.5, 7.0 | 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 | - | Machined |
| Angled Abutment | 4.5, 5.0, 5.5 | 8.0 | 1.0, 2.0, 3.0 | 15, 17, 25 | Machined |

The abutment's dimension range is as follows:

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| Abutment | Diameter (Ø) | Post Height (mm) | Cuff Height (mm) | Angulation (°) | Surface |
|-----------------------------------------------|---------------------------------|-----------------------|----------------------------|----------------|----------|
| Solid Abutment | 4.0, 4.5, 5.0, 5.5,<br>6.0, 6.5 | 4.0, 5.5, 7.0 | 1.0, 2.0, 3.0,<br>4.0, 5.0 | - | Machined |
| Multi-Unit Abutment | 4.8 | 2.3 | 1.0, 2.0, 3.0,<br>4.0, 5.0 | Straight | Machined |
| Multi-Unit Angled<br>Abutment | 4.5 | 2.3 | 2.0, 3.0, 4.0,<br>5.0 | 15, 17, 25 | Machined |
| Temporary Abutment | 4.0, 4.5, 5.0, 5.5,<br>6.0, 6.5 | 9.75, 10.75,<br>11.75 | 1.0, 2.0, 3.0 | - | Machined |
| Healing Abutment | 4.2, 4.7, 5.2, 5.7,<br>6.2, 6.7 | - | 3.0, 4.0, 5.0,<br>6.0, 7.0 | - | Machined |
| Abutment Screw, Multi-<br>Unit Abutment Screw | 2.05, 2.3 | 7.5, 9.5 | - | - | Machined |
| Cover Screw | 3.6 | 5.4 | - | - | Machined |

#### VII. INDICATION FOR USE

The Highness Implant System is designed to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (crowns, bridges, and overdentures) in partially or fully edentulous individuals. It is used to the restore the patient's chewing function. Implants with diameter less than ø5.5mm are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated to the molar region and are indicated for delayed loading.

The Multi-Unit Abutments are intended for multi-unit restorations only and can be used up to 25 degrees when connecting cylinder.

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#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VIII.

<Substantial Equivalence to Predicate Devices Table – Fixture>

| | SUBJECT Device | Primary PREDICATE Device<br>(K182448) | REFERENCE Device (K123988) | Significant Difference |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGenImplant Co., Ltd. | – |
| Trade Name | Highness Implant System | AnyRidge Octa 1 Implant System | AnyOne™ Internal Implant System | – |
| Regulation Description | Endosseous Dental Implant System | Endosseous Dental Implant System | Endosseous Dental Implant System | Identical |
| Regulation Number | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 | Identical |
| Product Code | DZE | DZE | DZE | Identical |
| Class | II | II | II | Identical |
| Indications for Use | The Highness Implant System is designed to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (crowns, bridges, and overdentures) in partially or fully edentulous individuals. It is used to the restore the patient's chewing function. Implants with diameter less than ø5.5mm are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated to the molar region | The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:<br>- Delayed loading.<br>- Immediate loading when good primary stability is achieved and with appropriate occlusal loading. | The AnyOne™ Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 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 | similar |
| | SUBJECT Device | Primary PREDICATE Device (K182448) | REFERENCE Device (K123988) | Significant Difference |
| Manufacturer | highness Co., Ltd.<br>and are indicated for delayed loading.<br>The Multi-Unit Abutments are intended for multi-unit restorations only and can be used up to 25 degrees when connecting cylinder. | MegaGen Implant Co., Ltd.<br>Larger implants are dedicated for the molar region. | MegaGenImplant Co., Ltd.<br>indicated for delayed loading. | – |
| Implant design | Root-form endosseous dental implants<br>Image: Subject Device Implant | Root-form endosseous dental implants<br>Image: Primary Predicate Device Implant | Root-form endosseous dental implants<br>Image: Reference Device Implant | Similar |
| Anti-Rotational Feature | Internal Hex | Internal Octa | Internal Hex | Similar |
| Diameter (ø) | HS-I:<br>4.2, 4.6, 5.1, 5.6, 6.0, 7.0 mm<br>HS-VII:<br>4.2, 4.7, 5.2, 5.7, 6.2, 7.0 mm | 3.6, 4.0, 4.4, 4.7, 4.8, 5.0, 5.5 mm | 3.9, 4.3, 4.8, 5.3, 6.3, 7.3 mm (for normal thread);<br>4.8, 5.8, 6.8, 7.8, 8.3 mm (for deep thread); and<br>4.8, 5.3, 6.3, 7.3 mm (for special length) | Similar |
| Length (mm) | 7.0, 8.5, 10, 11.5, 13, 14.5(not available for the 7.0mm diameter) mm | 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 mm | 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm (for normal and deep thread);<br>7.0 mm (for special length) | Similar |
| Raw material | CP Titanium Grade 4 | CP Titanium Grade 4 | CP Titanium Grade 4 and Ti-6A1-4V-ELI Titanium Alloy | Identical |
| Surface Treatment | SLA | SLA | SLA | Identical |
| | SUBJECT Device | Primary PREDICATE Device (K182448) | REFERENCE Device (K123988) | Significant Difference |
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGenImplant Co., Ltd. | - |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | Identical |
| Single Use | Yes | Yes | Yes | Identical |
| Biocompatibility | Biocompatible according to ISO 10993-1 | Biocompatible according to ISO 10993-1 | Biocompatible according to ISO 10993-1 | Identical |
| Principle of Operation | This product is a root-type fixture which is inserted in the alveolar bone. It replaces the functions of the missing teeth as a dental implant fixture. | This product is a tapered body fixture which is inserted in the alveolar bone. It replaces the functions of the missing teeth as a dental implant fixture. | This product is a tapered body fixture which is inserted in the alveolar bone. It replaces the functions of the missing teeth as a dental implant fixture. | Identical |
| Shelf-life | 5 years | 5 years | - | Identical |
| SE | Information provided in these 510(k) submissions shows that the Highness Implant System is substantially equivalent to the primary predicate device, in terms of indications for use, principle of operation, surface treatment, sterilization method, function and performance related to technological characteristics. Differences between the proposed and primary predicate device are not expected to affect the overall performance of the device.<br>There are slightly different diameter and length between the subject and primary predicate device. The implant length range of the subject device is within the range of the predicate devices. However, there is an additions diameter in the subject device comparing to the predicate device. The difference in length is minor, but the AnyOne ™ Internal Implant System was used by MegaGenImplant Co., Ltd. to support these lengths. And the reference device is made of the same material as the subject device, CP Ti Grade 4 same as our device material; it is not introducing significantly different design, and the performance test results supported that this difference does not raise an issue in performance. | | | |

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## <Substantial Equivalence to Predicate Devices Table – Abutment>

# 1) Cemented Abutment

| | SUBJECT Device | Primary PREDICATE Device<br>(K182448) | REFERENCE Device (K160519) | Significant Difference |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | OSSTEM Implant Co., Ltd | - |
| Trade Name | Cemented Abutment for | EZ Post Abutment for AnyRidge | Link Abutment for CEREC…