(266 days)
No
The 510(k) summary describes a physical dental implant system and its components, focusing on materials, mechanical testing, biocompatibility, and sterilization. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes.
The device is a dental implant system designed to restore the patient's chewing function, which is a therapeutic purpose.
No
Explanation: 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. It is a treatment device that restores chewing function, not a device used to diagnose a condition or disease.
No
The device description clearly states it is a titanium-metal dental implant system consisting of physical components (fixtures and abutments). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is designed for surgical placement in the jaw to provide support for dental restorations and restore chewing function. This is a therapeutic and structural purpose within the body.
- Device Description: The description details a physical implant system made of titanium, designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. IVDs are typically used in vitro (outside the body) to analyze biological samples.
The device described is a dental implant system, which is a type of medical device used for surgical implantation and prosthetic support, not for in vitro diagnostic testing.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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 |
| Solid Abutment | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | 4.0, 5.5, 7.0 | 1.0, 2.0, 3.0, 4.0, 5.0 | - | Machined |
| Multi-Unit Abutment | 4.8 | 2.3 | 1.0, 2.0, 3.0, 4.0, 5.0 | Straight | Machined |
| Multi-Unit Angled Abutment | 4.5 | 2.3 | 2.0, 3.0, 4.0, 5.0 | 15, 17, 25 | Machined |
| Temporary Abutment | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | 9.75, 10.75, 11.75 | 1.0, 2.0, 3.0 | - | Machined |
| Healing Abutment | 4.2, 4.7, 5.2, 5.7, 6.2, 6.7 | - | 3.0, 4.0, 5.0, 6.0, 7.0 | - | Machined |
| Abutment Screw, Multi-Unit Abutment Screw | 2.05, 2.3 | 7.5, 9.5 | - | - | Machined |
| Cover Screw | 3.6 | 5.4 | - | - | Machined |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arches (jaw bone)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Fatigue: Dynamic fatigue testing mechanical testing of the proposed Highness Implant System was performed in accordance with ISO 14801:2016, "Dentistry – Implants – Dynamic loading test for endosseous dental implants", and FDA guidance on "Root-form Endosseous Dental Implants and Endosseous Dental Abutments – Class II Special Controls Guidance Document for Industry and FDA Staff". The test articles were able to withstand 5,000,000 cycles without failure under substantially equivalent loading to the cited primary predicate device cleared under K182448.
SLA Surface Treatment: The Highness Implant System utilizes an SLA (Sand-blasted, Large grit, Acid-etched) surface treatment for its fixtures. Cleaning validation and SEM/EDS (Scanning Electron Microscopy/Energy Dispersive X-ray Spectroscopy) analysis were performed on the proposed device to ensure the removal of any particles or chemicals used during the process. The SEM/EDS analysis confirms that no elements other than titanium were found on the surface of the implant.
Biocompatibility: Biocompatibility classification is based on the FDA Guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process." The subject devices are classified as the implant medical devices, tissue/bone, long-term exposure (>30 days). The subject devices have fulfilled all testing required per ISO 7405:2018, "Dentistry -Evaluation of biocompatibility of medical devices used in dentistry", ISO 10993-1:2018, "Biological evaluation of medical devices – Part 1: Evaluation and testing" and the FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Cytotoxicity testing was conducted as per ISO 10993-5:2019, "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity". Cytotoxicity testing was conducted as per ISO 10993-5:2009, "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity".
Sterilization and Shelf Life: Similar to the Predicate Devices, the Highness Implant System is packaged in an aluminum pouch and supplied sterile and non-sterile. The non-sterile abutments used in the surgery must be sterilized by the end user, prior to use, as stated in the IFU. User moist heat sterilization for the subject non-sterile devices was conducted according to, ISO 17665-1:2006, "Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices", and ISO/TS 17665-2:2009, "Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1" and demonstrated a SAL of 10-6. The sterile implants (fixtures), following to gamma sterilization and packaging were subjected to sterile barrier testing to validate a shelf life of 5 years according to ISO 11607-1:2019, "Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems" and ISO 11607-2:2019, "Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes" confirm the stability and effectiveness of the packaging of the sterilized product during the shelf life, by evaluating changes due to accelerated aging, according to ASTM F1980-21, "Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices". For the sterile implants, gamma sterilization validation of the fixtures was performed in accordance with ISO 11137-1:2006, "Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices", ISO 11137-2:2013, "Sterilization of health care products – Radiation - Part 2: Establishing the sterilization dose", and ISO 11137-3:2017, "Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects of development, validation and routine control". In addition, for sterile fixtures, bacterial endotoxin testing was performed on sterile devices in accordance with ANSI/AAMI ST72:2019, "Bacterial Endotoxins - Test Methods, Routine Monitoring, And Alternatives To Batch Testing" using the Limulus Amebocyte Lysate (LAL) pyrogen test method at a test limit of 20 EU/device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K123988, K192347, K203808, K110955, K160519
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
3
DEPARTMENT0 OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
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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4
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: +82-1566-0728 Fax: +82-54-973-0728 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: +82-10-4952-6638 Office Phone: +82-70-7807-0550 Contact: Ms. Sang-hwa Myung, Regulatory Affair Specialist Email: mshenmc@gmail.com
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.
5
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:
6
| Abutment | Diameter (Ø) | Post Height (mm) | Cuff Height (mm) | Angulation (°) | Surface |
|---|---|---|---|---|---|
| Solid Abutment | 4.0, 4.5, 5.0, 5.5, | ||||
| 6.0, 6.5 | 4.0, 5.5, 7.0 | 1.0, 2.0, 3.0, | |||
| 4.0, 5.0 | - | Machined | |||
| Multi-Unit Abutment | 4.8 | 2.3 | 1.0, 2.0, 3.0, | ||
| 4.0, 5.0 | Straight | Machined | |||
| Multi-Unit Angled | |||||
| Abutment | 4.5 | 2.3 | 2.0, 3.0, 4.0, | ||
| 5.0 | 15, 17, 25 | Machined | |||
| Temporary Abutment | 4.0, 4.5, 5.0, 5.5, | ||||
| 6.0, 6.5 | 9.75, 10.75, | ||||
| 11.75 | 1.0, 2.0, 3.0 | - | Machined | ||
| Healing Abutment | 4.2, 4.7, 5.2, 5.7, | ||||
| 6.2, 6.7 | - | 3.0, 4.0, 5.0, | |||
| 6.0, 7.0 | - | Machined | |||
| Abutment Screw, Multi- | |||||
| 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.
7
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VIII.
| | SUBJECT Device | Primary PREDICATE Device
(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:
- Delayed loading.
- 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.
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. | MegaGen Implant Co., Ltd.
Larger implants are dedicated for the molar region. | MegaGenImplant Co., Ltd.
indicated for delayed loading. | – |
| Implant design | Root-form endosseous dental implants
Image: Subject Device Implant | Root-form endosseous dental implants
Image: Primary Predicate Device Implant | Root-form endosseous dental implants
Image: Reference Device Implant | Similar |
| Anti-Rotational Feature | Internal Hex | Internal Octa | Internal Hex | Similar |
| Diameter (ø) | HS-I:
4.2, 4.6, 5.1, 5.6, 6.0, 7.0 mm
HS-VII:
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);
4.8, 5.8, 6.8, 7.8, 8.3 mm (for deep thread); and
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);
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.
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. | | | |
8
9
1) Cemented Abutment
| | SUBJECT Device | Primary PREDICATE Device
(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 | - |
| | SUBJECT Device | Primary PREDICATE Device
(K182448) | REFERENCE Device (K160519) | Significant Difference |
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | OSSTEM Implant Co., Ltd | – |
| Regulation Description | Highness Implant System
Endosseous Dental Implant
System | Octa 1 System
Endosseous Dental Implant
System | Endosseous Dental Implant
System | Identical |
| Regulation Number | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical |
| Product Code | NHA | NHA | NHA | Identical |
| Class | II | II | II | Identical |
| Indications | 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 | 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:
-Delayed loading,
-Immediate loading when good
primary stability is achieved
and with appropriate occlusal
loading.
Larger implants are dedicated
for the molar region. | The Link Abutment for CEREC is
titanium alloy abutments
placed onto HIOSSEN dental
implants to provide support for
customized prosthetic
restorations.
Link Abutment for CEREC is
indicated for screw-retained
single tooth or cement-
retained single tooth and
bridge restorations. - Link
abutment for CEREC
All digitally designed copings
and/or crowns for use with the
Link abutment for CEREC is to
be scanned using Sirona CEREC
AC or CEREC AF or CEREC AI,
designed using Sirona inLab
software (Version 3.65) or
Sirona CEREC Software (Version
4.2) and manufactured using a | Similar: Indications for use of the
subject device is slightly different
from the primary predicate in
phrase but fundamental indication
from the reference devices is the
identical. |
| | SUBJECT Device | Primary PREDICATE Device
(K182448) | REFERENCE Device (K160519) | Significant Difference |
| Manufacturer | highness Co., Ltd.
intended for multi-unit
restorations only and can be
used up to 25 degrees when
connecting cylinder. | MegaGen Implant Co., Ltd. | OSSTEM Implant Co., Ltd
Sirona CEREC or inLab MC X or
MC XL milling unit. CAD/CAM
manufacturing/milling occurs
at dental laboratories per the
design limitations of the Sirona
CEREC. | – |
| Design | Image: highness Co., Ltd. design | Image: MegaGen Implant Co., Ltd. design | Image: OSSTEM Implant Co., Ltd design | Similar |
| Diameter (ø) | 4.5, 5.0, 5.5, 6.0, 6.5 mm | 4.0, 5.0, 6.0, 7.0 mm | 4.5 mm | Similar |
| Post Height | 4.0, 5.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm | 4.7 mm | Identical |
| Cuff Height | 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 mm | 0.8, 1.8, 2.8, 3.8, 4.8 mm | 0.5 mm | Similar |
| Raw material | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Identical |
| Connection Interface | Hex, Non-hex | Octa, Non-octa | Hex, Non-hex | Similar |
| Surface Treatment | Non-Anodizing | Anodizing | | Identical |
| Sterilization | Non-sterile; Steam sterilization
prior to use | Non-sterile; Steam sterilization
prior to use | Non-sterile; Steam sterilization
prior to use | Identical |
| Single Use | Yes | Yes | Yes | Identical |
| Restoration type | Single & Multi | Single & Multi | Single & Multi | Identical |
| Biocompatibility | Biocompatible in accordance
with ISO 10993-1 | Biocompatible in accordance
with ISO 10993-1 | Biocompatible in accordance
with ISO 10993-1- | Identical |
| Principle of Operation | This product is a superstructure
which is connects with the
fixtures using the Abutment
Screw. It replaces the functions | This product is a superstructure
which is connects with the
fixtures using the Abutment
Screw. It replaces the functions | This product is a superstructure
which is connects with the
fixtures using the Abutment
Screw. It replaces the functions | Identical |
| | SUBJECT Device | Primary PREDICATE Device
(K182448) | REFERENCE Device (K160519) | Significant Difference |
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | OSSTEM Implant Co., Ltd | – |
| | of the missing teeth as a dental
abutment. | of the missing teeth as a dental
abutment. | of the missing teeth as a dental
abutment. | |
| SE | The subject device has the same intended use, material, principle of operation and similar design as the predicate device and re, and
there are slightly different dimensions. However, the abutment diameter and angulation range of the subject device is within the range
of the predicate device. And the subject device has slightly different of post height and Cuff Height. However, this post height and gingival
range is to meet each patient needs and does not raise an issue in performance or safety since the size difference is very minor. Also,
the connection interface is different but both features of Octa and Hex provides anti-rotational feature. Therefore, it is substantial
equivalent. | | | |
10
11
12
2) Angled Abutment
| SUBJECT Device | Primary PREDICATE Device (K182448) | Significant Difference | |
|---|---|---|---|
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | – |
| Trade Name | Angled Abutment for Highness Implant System | Angled Abutment for AnyRidge Octa 1 System | – |
| Regulation | |||
| Description | Endosseous Dental Implant System | Endosseous Dental Implant System | Identical |
| Regulation | |||
| Number | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical |
| Product Code | NHA | NHA | Identical |
| Class | II | II | Identical |
| Indications | 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 | 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: | Identical |
| SUBJECT Device | |||
| Primary PREDICATE Device (K182448) | Significant Difference | ||
| Manufacturer | highness Co., Ltd. | ||
| 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. | MegaGen Implant Co., Ltd. | ||
| -Delayed loading, | |||
| -Immediate loading when good primary stability is | |||
| achieved and with appropriate occlusal loading. | |||
| Larger implants are dedicated for the molar region. | - | ||
| Design | Image: highness Co., Ltd. | Image: MegaGen Implant Co., Ltd. | Similar |
| Diameter (ø) | 4.5, 5.0, 5.5 mm | 4.0, 5.0, 6.0, 7.0 mm | Similar |
| Post Height | 8.0 mm | 7.0 mm | Similar |
| Cuff Height | 1.0, 2.0, 3.0, 4.0, 5.0 mm | 0.8, 1.8, 2.8, 3.8, 4.8 mm | Similar |
| Angulation | 15°, 17°, 25° | 15°, 25° | Similar |
| Raw material | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Identical |
| Connection | Hex, Non-hex | Octa, Non-octa | Similar |
| Interface | - | - | - |
| Surface | Non-Anodizing | Anodizing | Identical |
| Treatment | - | - | - |
| Sterilization | Non-sterile; Steam sterilization prior to use | Non-sterile; Steam sterilization prior to use | Identical |
| Single Use | Yes | Yes | Identical |
| Restoration | |||
| type | Single & Multi | Single & Multi | Identical |
| Biocompatibility | Biocompatible in accordance with ISO 10993-1 | Biocompatible in accordance with ISO 10993-1 | Identical |
| Principle of | |||
| Operation | This product is a superstructure which is connects with | ||
| the fixtures using the Abutment Screw. It replaces the | |||
| functions of the missing teeth as a dental abutment. | This product is a superstructure which is connects | ||
| with the fixtures using the Abutment Screw. It | |||
| replaces the functions of the missing teeth as a | Identical | ||
| SUBJECT Device | Primary PREDICATE Device (K182448) | Significant Difference | |
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | – |
| dental abutment. | |||
| SE | The subject device has the same intended use, material, principle of operation and similar design as the predicate device, and there are slightly different dimensions. However, the abutment diameter and angulation range of the subject device is within the range of the predicate device. And the subject device has slightly different of post height and Cuff Height. However, this post height and gingival range is to meet each patient needs and does not raise an issue in performance or safety since the size difference is very minor. Also, the connection interface is different but both features of Octa and Hex provides anti-rotational feature. Therefore, it is substantial equivalent. |
13
14
3) Solid Abutment
| | SUBJECT Device | Primary PREDICATE Device
(K182448) | REFERENCE Device (K192347) | Significant Difference |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | Megagen Implant Co. Ltd. | – |
| Trade Name | Solid Abutment for Highness
Implant System | Octa Abutment For AnyRidge
Octa 1 System | Solid Abutment for ST Internal
Implant System | – |
| Regulation Description | Endosseous Dental Implant
System | Endosseous Dental Implant
System | Endosseous Dental Implant
System | Identical |
| Regulation Number | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical |
| Product Code | NHA | NHA | NHA | Identical |
| Class | II | II | II | Identical |
| Indications | 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 | 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 | The ST Internal Implant System
is intended to be surgically
placed in the maxillary or
mandibular arches 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 | Identical |
| | SUBJECT Device | Primary PREDICATE Device
(K182448) | REFERENCE Device (K192347) | Significant Difference |
| Manufacturer | highness Co., Ltd.
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. | MegaGen Implant Co., Ltd.
chewing function in the
following situations and with
the clinical protocols:
-Delayed loading,
-Immediate loading when good
primary stability is achieved
and with appropriate occlusal
loading.
Larger implants are dedicated
for the molar region. | Megagen Implant Co. Ltd.
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
indicated for delayed loading. | – |
| Design | Image: abutment | Image: abutment | Image: abutment | Similar |
| Diameter (ø) | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 mm | 3.8 mm | 4.0, 4.6, 5.0, 6.0, 7.0 mm | Similar |
| Post Height | 4.0, 5.5, 7.0 mm | Unknown | 4.0, 5.5, 7.0 mm | Similar |
| Cuff Height | 1.0, 2.0, 3.0, 4.0, 5.0 mm | 0.8, 1.8, 2.8, 3.8, 4.8 mm | 1.0, 2.0, 3.0, 4.0, 5.0 mm | Similar |
| Raw material | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Identical |
| Connection Interface | Hex | Internal Conical connection | Hex | Similar |
| Surface Treatment | Non-Anodizing | Color anodization | Anodizing | Similar |
| Sterilization | Non-sterile: Steam sterilization | Non-sterile: Steam sterilization | Non-Sterile (user sterilization). | Identical |
| | SUBJECT Device | Primary PREDICATE Device
(K182448) | REFERENCE Device (K192347) | Significant Difference |
| Manufacturer | highness Co., Ltd.
prior to use | MegaGen Implant Co., Ltd.
prior to use | Megagen Implant Co. Ltd.
or sterile (Radiation) | - |
| Single Use | Yes | Yes | Yes | Identical |
| Restoration type | Single & Multi | Single & Multi | Single & Multi | Identical |
| Biocompatibility | Biocompatible in accordance
with ISO 10993-1 | Biocompatible in accordance
with ISO 10993-1 | Biocompatible in accordance
with ISO 10993-1 | Identical |
| Principle of Operation | This product is a superstructure
which is connects with the
fixtures using the Abutment
Screw. It replaces the functions
of the missing teeth as a dental
abutment. | This product is a superstructure
which is connects with the
fixtures using the Abutment
Screw. It replaces the functions
of the missing teeth as a dental
abutment. | This product is a superstructure
which is connects with the
fixtures using the Abutment
Screw. It replaces the functions
of the missing teeth as a dental
abutment. | Identical |
| SE | The subject device has the same intended use, material, principle of operation and similar design as the primary predicate, and there
are different dimensions. However, the abutment diameter, post height and Cuff Height range of the subject device is within the range
of the reference device. These differences do not affect product's fundamental function. Also, the connection interface is different but
both features of Octa and Hex provides anti-rotational feature. Therefore, it is substantial equivalent. | | | |
15
16
4) Multi-Unit Abutment
| | SUBJECT Device | Primary PREDICATE Device
(K182448) | REFERENCE Device (K203808) | Significant Difference |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | – |
| Trade Name | Multi Angled Abutment for
Highness Implant System | Multi-unit Abutment For Multi-
unit Abutment, Multi-unit
Angled Abutment | Multi-unit Abutment For Multi-
unit Abutment, Multi-unit
Angled Abutment | – |
| Regulation Description | Endosseous Dental Implant
System | Endosseous Dental Implant
System | Endosseous Dental Implant
System | Identical |
| Regulation Number | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical |
| Product Code | NHA | NHA | NHA | Identical |
| | SUBJECT Device | Primary PREDICATE Device (K182448) | REFERENCE Device (K203808) | Significant Difference |
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | - |
| Class | II | II | II | Identical |
| Indications | 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 $ø$ 5.5mm 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. | The Multi-unit Abutment, Multi-unit Angled Abutment is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. | The Multi-unit Abutment, Multi-unit Angled Abutment is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. | Identical |
| | SUBJECT Device | Primary PREDICATE Device
(K182448) | REFERENCE Device (K203808) | Significant Difference |
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | – |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Image: Reference Device Design | Similar |
| Diameter (ø) | 4.8 mm | 4.8, 5.0 mm | 4.8, 5.0 mm | Identical |
| Post Height | 2.3 mm | 1.8, 2.2 mm | 1.8, 2.2 mm | Similar |
| Cuff Height | 1.0, 2.0, 3.0, 4.0, 5.0 mm | 0.6, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0,
4.5, 5.0, 5.5 mm | 0.6, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0,
4.5, 5.0, 5.5 mm | Similar |
| Angulation | Straight | Straight | Straight | Identical |
| Raw material | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Identical |
| Connection Interface | Hex | Octa, Non-octa | Internal Hex, Internal Non-Hex,
Internal Conical Connection | Similar |
| Surface Treatment | Non-Anodizing | Color Anodization | Anodizing | Similar |
| Sterilization | Non-sterile; Steam sterilization
prior to use | Non-sterile; Steam sterilization
prior to use | Non-sterile; Steam sterilization
prior to use | Identical |
| Single Use | Yes | Yes | Yes | Identical |
| Restoration type | Multi | Single & Multi | Single & Multi | Identical |
| Biocompatibility | Biocompatible in accordance
with ISO 10993-1 | Biocompatible in accordance
with ISO 10993-1 | Biocompatible in accordance
with ISO 10993-1 | Identical |
| Principle of Operation | This product is a premanufactured
prosthetic component directly
connected to the endosseous
dental implant and is intended for
use as an aid in prosthetic
rehabilitation. | Multi-unit Abutment is a
premanufactured prosthetic
component directly connected to
the endosseous dental implant
and is intended for use as an aid in
prosthetic rehabilitation. | This product is a pre-manufactured
prosthetic component directly or
indirectly connected to the
endosseous dental implant using
its threaded part or screw for aid
in prosthetic rehabilitation. | Identical |
| SE | The subject device has the same intended use, material, principle of operation and similar design as the predicate device, and there is | | | |
| | slightly different Cuff Height. However, the Cuff Height range of the subject device is within the range of the reference device. And the | | | |
| | subject device has slightly different post height. However, this post height range is to meet each patient needs and does not raise an | | | |
| | SUBJECT Device | Primary PREDICATE Device
(K182448) | REFERENCE Device (K203808) | Significant Difference |
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | - |
| | issue in performance or safety since the size difference is very minor. Also, the connection interface is different but both features of Octa
and Hex provides anti-rotational feature. Therefore, it is substantial equivalent. | | | |
17
18
19
5) Multi-Unit Angled Abutment
| SUBJECT Device | Primary PREDICATE Device (K182448) | REFERENCE Device (K203808) | Significant Difference | |
|---|---|---|---|---|
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | – |
| Trade Name | Multi Angled Abutment for Highness Implant System | Multi-unit Angled Abutment for AnyRidge Octa 1 System | Multi-unit Angled Abutment For Multi-unit Abutment, Multi-unit Angled Abutment | – |
| Regulation Description | Endosseous Dental Implant System | Endosseous Dental Implant System | Endosseous Dental Implant System | Identical |
| Regulation Number | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical |
| Product Code | NHA | NHA | NHA | Identical |
| Class | II | II | II | Identical |
| Indications | 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. | 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 | The Multi-unit Abutment, Multi-unit Angled Abutment is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. | Identical |
| SUBJECT Device | Primary PREDICATE Device | |||
| (K182448) | REFERENCE Device (K203808) | Significant Difference | ||
| Manufacturer | highness Co., Ltd. | |||
| 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. | MegaGen Implant Co., Ltd. | |||
| following situations and with | ||||
| the clinical protocols: | ||||
| -Delayed loading, | ||||
| -Immediate loading when good | ||||
| primary stability is achieved | ||||
| and with appropriate occlusal | ||||
| loading. | ||||
| Larger implants are dedicated | ||||
| for the molar region. | MegaGen Implant Co., Ltd. | – | ||
| Design | Image: Implant design | Image: Implant design | Image: Implant design | Similar |
| Diameter (ø) | 4.5 mm | 4.8 mm | 4.8, 5.0 mm | Identical |
| Cuff Height | 2.0, 3.0, 4.0, 5.0 mm | 2.3, 3.3, 4.3 mm | 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, | |
| 4.5 mm | Similar | |||
| Angulation | 15°, 17°, 25° | 17°, 30° | 17°, 29°, 30° | Similar |
| Raw material | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Identical |
| Connection Interface | Hex | Octa, Non-octa | Internal Hex, Internal Non-Hex, | |
| Internal Octa, Internal Non- | ||||
| Octa | Similar | |||
| Surface Treatment | Non-Anodizing | Non-Anodizing | Anodizing | Identical |
| Sterilization | Non-sterile; Steam sterilization | Non-sterile; Steam sterilization | Non-Sterile (user sterilization), | Identical |
| SUBJECT Device | Primary PREDICATE Device | |||
| (K182448) | REFERENCE Device (K203808) | Significant Difference | ||
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | - |
| prior to use | prior to use | or sterile (Radiation) | ||
| Single Use | Yes | Yes | Yes | Identical |
| Restoration type | Multi | Single & Multi | Single & Multi | Identical |
| Biocompatibility | Biocompatible in accordance | |||
| with ISO 10993-1 | Biocompatible in accordance | |||
| with ISO 10993-1 | Biocompatible in accordance | |||
| with ISO 10993-1 | Identical | |||
| Principle of Operation | Multi-unit Angled Abutment is a | |||
| premanufactured prosthetic | ||||
| component directly connected to | ||||
| the endosseous dental implant | ||||
| and is intended for use as an aid in | ||||
| prosthetic rehabilitation. | Multi-unit Angled Abutment is a | |||
| premanufactured prosthetic | ||||
| component directly connected to | ||||
| the endosseous dental implant | ||||
| and is intended for use as an aid in | ||||
| prosthetic rehabilitation. | This product is a pre-manufactured | |||
| prosthetic component directly | ||||
| connected to the endosseous | ||||
| dental implant using the screw and | ||||
| is intended for use as an aid in | ||||
| prosthetic rehabilitation. | Identical | |||
| SE | The subject device has the same intended use, material, principle of operation and similar design as the primary predicate, and there | |||
| are different dimensions. However, the abutment diameter, Cuff Height and angulation range of the subject device is within the range | ||||
| of the reference device. These differences do not affect product's fundamental function. Also, the connection interface is different but | ||||
| both features of Octa and Hex provides anti-rotational feature. Therefore, it is substantial equivalent. |
20
21
6) Multi-unit Abutment Screw & Abutment Screw
| | SUBJECT Device | Primary PREDICATE Device
(K182448) | REFERENCE Device (K203808) | Significant Difference |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | - |
| Trade Name | Abutment Screw, Multi-unit
Abutment Screw for Highness
Implant System | Multi-unit Abutment Screw For
AnyRidge Octa 1 Implant
System | Multi Angled Abutment Screw | - |
| Regulation Description | Endosseous Dental Implant
System | Endosseous Dental Implant
System | Endosseous Dental Implant
System | Identical |
| Regulation Number | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical |
| Product Code | NHA | NHA | NHA | Identical |
| | SUBJECT Device | Primary PREDICATE Device (K182448) | REFERENCE Device (K203808) | Significant Difference |
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | – |
| Class | II | II | II | Identical |
| Indications | 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. | 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: -Delayed loading, -Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region. | The Multi-unit Abutment, Multi-unit Angled Abutment is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. | Identical |
| | SUBJECT Device | Primary PREDICATE Device (K182448) | REFERENCE Device (K203808) | Significant Difference |
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | - |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Image: Reference Device Design | Similar |
| Diameter (ø) | 2.05 mm;
2.3 mm | 2.1, 2.2 mm | 2.1, 2.2, 2.4, 2.95 mm | Similar |
| Total Length | 7.5 mm;
9.5 mm | 7.0, 7.9 mm | 4.4, 6.8, 7.0, 10.8, 11.5, 11.8, 12.5, 12.8, 13.5, 13.8, 14.5, 15.5 mm | Similar |
| Raw material | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Identical |
| Connection Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection | Identical |
| Surface Treatment | Machined | Machined | Machined, Anodizing | Identical |
| Sterilization | Non-sterile; Steam sterilization prior to use | Non-sterile; Steam sterilization prior to use | Non-Sterile (user sterilization), or sterile (Radiation) | Identical |
| Single Use | Yes | Yes | Yes | Identical |
| Restoration type | Single & Multi | Single & Multi | Single & Multi | Identical |
| Biocompatibility | Biocompatible in accordance with ISO 10993-1 | Biocompatible in accordance with ISO 10993-1 | | Identical |
| Principle of Operation | Abutment Screw and Multi-unit Abutment Screw is used for connecting Abutment or Multi-unit Abutment or Multi-unit Angled Abutment to the fixture. | Multi-unit Abutment Screw is used for connecting Multi-unit Abutment or Multi-unit Angled Abutment to the fixture. | Multi-unit Abutment Screw is used for connecting Multi-unit Abutment or Multi-unit Angled Abutment to the fixture. | Identical |
| SE | The subject device has the same intended use, material, principle of operation and similar design as the primary predicate, and there are different dimensions. However, the abutment diameter, Cuff Height and angulation range of the subject device is within the range of the reference device. These differences do not affect product's fundamental function. Also, the connection interface is different but | | | |
| | SUBJECT Device | Primary PREDICATE Device | REFERENCE Device (K203808) | Significant Difference |
| | | (K182448) | | |
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | - |
| | both features of Octa and Hex provides anti-rotational feature. Therefore, it is substantial equivalent. | | | |
22
23
24
7) Temporary Abutment
| SUBJECT Device | Primary PREDICATE Device (K182448) | Significant Difference | ||
|---|---|---|---|---|
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | - | |
| Trade Name | Temporary Abutment for Highness Implant System | Temporary Abutment for AnyRidge Octa 1 System | - | |
| Regulation Description | Endosseous Dental Implant System | Endosseous Dental Implant System | - | |
| Regulation Number | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical | |
| Product Code | NHA | NHA | Identical | |
| Class | II | II | Identical | |
| Indications | 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 | 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: | ||||
| -Delayed loading, | ||||
| -Immediate loading when good primary | ||||
| stability is achieved and with appropriate | ||||
| occlusal loading. | ||||
| Larger implants are dedicated for the molar | ||||
| region. | Identical | |||
| SUBJECT Device | Primary PREDICATE Device (K182448) | Significant Difference | ||
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | - | |
| up to 25 degrees when connecting cylinder. | ||||
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Similar | |
| Diameter (ø) | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 mm | 4.0, 5.0 mm | Similar | |
| Post Height | 9.75, 10.75, 11.75 mm | 10 mm | Similar | |
| Cuff Height | 1.0, 2.0, 3.0 mm | 2.0, 3.0 mm | Similar | |
| Angulation | 0° | 0° | Identical | |
| Raw material | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Identical | |
| Connection Interface | Hex, Non-Hex | Octa, Non-octa | Similar | |
| Surface Treatment | Non-Anodizing | Color Anodization | Similar | |
| Sterilization | Non-sterile; Steam sterilization prior to use | Non-sterile; Steam sterilization prior to use | Identical | |
| Single Use | Yes | Yes | Identical | |
| Restoration type | Single & Multi | Single & Multi | Identical | |
| Biocompatibility | Biocompatible in accordance with ISO 10993-1 | Biocompatible in accordance with ISO 10993-1 | Identical | |
| Principle of Operation | Temporary Abutment is used in conjunction | |||
| with fixture to provide support for provisional | ||||
| restoration. | Temporary Abutment is used in conjunction | |||
| with fixture to provide support for provisional | ||||
| restoration. | Identical | |||
| SE | The subject device has the same intended use, material, principle of operation and similar design as the predicate device. However, | |||
| there are different dimensions. The subject device has slightly wider range of diameter, post height and Cuff Height. This wider range is | ||||
| to meet each patient needs and does not raise an issue in performance or safety since the size difference is very minor; therefore, it is | ||||
| substantial equivalent. Also, the connection interface is also different but both features of Octa and Hex provides anti-rotational feature. | ||||
| SUBJECT Device | Primary PREDICATE Device | REFERENCE Device (K110955) | Significant Difference | |
| (K182448) | ||||
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | - |
| Trade Name | Healing Abutment for Highness | Healing Abutment for AnyRidge | Healing Abutment for AnyRidge | - |
| Implant System | Octa 1 System | Internal System | ||
| Regulation Description | Endosseous Dental Implant | Endosseous Dental Implant | Endosseous Dental Implant | Identical |
| System | System | System | ||
| Regulation Number | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical |
| Product Code | NHA | NHA | NHA | Identical |
| Class | II | II | II | Identical |
| Indications | The Highness Implant System is | The AnyRidge Octa 1 Implant | The AnyRidge Internal Implant | Identical |
| designed to be surgically | System is intended to be | System is intended to be | ||
| placed in the maxillary or | surgically placed in the | surgically placed in the | ||
| mandibular arches for the | maxillary or mandibular arches | maxillary or mandibular molar | ||
| purpose of providing prosthetic | for the purpose of providing | areas for the purpose providing | ||
| support for dental restorations | prosthetic support for dental | prosthetic support for dental | ||
| (crowns, bridges, and | restorations (Crown, bridges, | restorations (Crown, bridges, | ||
| overdentures) in partially or | and overdentures) in partially | and overdentures) in partially | ||
| fully edentulous individuals. It | or fully edentulous individuals. | or fully edentulous individuals. | ||
| is used to the restore the | It is used to restore a patient's | It is used to restore a patient's | ||
| patient's chewing function. | chewing function in the | chewing function. Smaller | ||
| Implants with diameter less | following situations and with | implants (less than 6.0 mm) are | ||
| than ø5.5mm are intended for | the clinical protocols: | dedicated for immediate | ||
| immediate loading when good | -Delayed loading, | loading when good primary | ||
| primary stability is achieved | -Immediate loading when good | stability is achieved and with | ||
| and with appropriate occlusal | primary stability is achieved | appropriate occlusal loading. | ||
| loading. Larger implants are | and with appropriate occlusal | Larger implants are dedicated | ||
| dedicated to the molar region | loading. | for the molar region and are | ||
| and are indicated for delayed | Larger implants are dedicated | indicated for delayed loading. | ||
| loading. | for the molar region. | |||
| SUBJECT Device | Primary PREDICATE Device | |||
| (K182448) | REFERENCE Device (K110955) | Significant Difference | ||
| Manufacturer | highness Co., Ltd. | |||
| 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. | MegaGen Implant Co., Ltd. | - | |
| Design | ||||
| Image: Subject Device Design | ||||
| Image: Primary Predicate Device Design | ||||
| Image: Reference Device Design | Similar | |||
| Diameter (ø) | 4.2, 4.7, 5.2, 5.7, 6.2, 6.7 mm | 3.2, 4.2, 5.2, 6.2 mm | 4.2, 5.2, 6.2, 7.2, 8.0, 10.0 mm | Similar |
| Cuff Height | 3.0, 4.0, 5.0, 6.0, 7.0 mm | 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5 mm | 3.5, 4.5, 5.5, 6.5, 7.5 mm | Similar |
| Raw material | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Identical |
| Connection Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection | Identical |
| Surface Treatment | Machined | Color Anodization | Machined | Similar |
| Sterilization | Non-sterile; Steam sterilization | |||
| prior to use | Non-sterile; Steam sterilization | |||
| prior to use | Non-Sterile (user sterilization), | |||
| or sterile (Radiation) | Identical | |||
| Single Use | Yes | Yes | Yes | Identical |
| Restoration type | Single & Multi | Single & Multi | Single & Multi | Identical |
| Biocompatibility | Biocompatible in accordance | |||
| with ISO 10993-1 | Biocompatible in accordance | |||
| with ISO 10993-1 | Biocompatible in accordance | |||
| with ISO 10993-1 | Identical | |||
| Principle of Operation | The Healing Abutment is | |||
| fastened into the female screw | ||||
| of dental implant and support | ||||
| the gingival shaping. | The Healing Abutment is | |||
| fastened into the female screw | ||||
| of dental implant and support | ||||
| the gingival shaping. | The Healing Abutment is | |||
| fastened into the female screw | ||||
| of dental implant and support | ||||
| the gingival shaping. | Identical | |||
| SE | The subject device has the same intended use, principle of operation, material, connection interface, and similar design as the predicate | |||
| devices, and there are slightly different diameter and cuff height. However, the diameter and cuff height range of the subject device is | ||||
| SUBJECT Device | Primary PREDICATE Device | |||
| (K182448) | REFERENCE Device (K110955) | Significant Difference | ||
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | - |
| within the range of the predicate devices. However, this diameter and cuff height range is to meet each patient needs and does not raise | ||||
| an issue in performance or safety since the size difference is very minor. The other difference is in surface treatment, but we already | ||||
| presented multiple predicate devices for anodizing in the other component comparison charts. Therefore, it is substantial equivalent. |
25
8) Healing Abutment
26
27
28
9) Cover Screw
| SUBJECT Device | Primary PREDICATE Device (K182448) | Significant Difference | |
|---|---|---|---|
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | - |
| Trade Name | Cover Screw for Highness Implant | ||
| System | Cover Screw For AnyRidge Octa 1 | ||
| Implant System | - | ||
| Regulation Description | Endosseous Dental Implant System | Endosseous Dental Implant System | - |
| Regulation Number | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical |
| Product Code | NHA | NHA | Identical |
| Class | II | II | Identical |
| Indications | 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 | 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: | |||
| -Delayed loading, | |||
| -Immediate loading when good | |||
| primary stability is achieved and with | |||
| appropriate occlusal loading. | Identical |
29
| SUBJECT Device | Primary PREDICATE Device (K182448) | Significant Difference | |
|---|---|---|---|
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | – |
| molar region and are indicated for | Larger implants are dedicated for the | ||
| delayed loading. | molar region. | ||
| The Multi-Unit Abutments are | |||
| intended for multi-unit restorations | |||
| only and can be used up to 25 degrees | |||
| when connecting cylinder. | |||
| Design | Image: Design | Image: Design | Similar |
| Diameter (ø) | 3.6 mm | 3.0, 3.7, 5.0, 6.0 mm | Similar |
| Length | 5.4 mm | 6.6, 7.1 mm | Similar |
| Raw material | Ti-6Al-4V ELI Titanium Alloy | Ti-6Al-4V ELI Titanium Alloy | Identical |
| Connection Interface | Internal Conical Connection | Internal Conical Connection | Identical |
| Surface Treatment | Machined | Anodizing | Similar |
| Sterilization | Non-sterile; Steam sterilization prior to | Non-sterile; Steam sterilization prior to | Identical |
| use | use | ||
| Single Use | Yes | Yes | Identical |
| Restoration type | Single & Multi | Single & Multi | Identical |
| Biocompatibility | Biocompatible according to ISO 10993- | Biocompatible according to ISO 10993- | Identical |
| 1 | 1 | ||
| Principle of Operation | Cover Screw is used for protecting the | Cover Screw is used for protecting the | Identical |
| inner structure of a fixture, and | inner structure of a fixture, and | ||
| exposed fixture platform after fixture | exposed fixture platform after fixture | ||
| placement. | placement. | ||
| SE | The subject device has the same intended use, principle of operation, material, connection interface, and similar design as | ||
| the predicate device, and there are slightly different diameter and length. However, the diameter and length range of the | |||
| subject device is within the range of the predicate device. However, this diameter and length range is to meet each patient | |||
| SUBJECT Device | Primary PREDICATE Device (K182448) | Significant Difference | |
| Manufacturer | highness Co., Ltd. | MegaGen Implant Co., Ltd. | - |
| needs and does not raise an issue in performance or safety since the size difference is very minor. The other difference is in | |||
| surface treatment, but we already presented multiple predicate device for anodizing in the other component comparison | |||
| charts. Therefore, it is substantial equivalent. |
30
31
IX. NONCLINICAL TEST
The following performance data was provided in support of the substantial equivalence determination.
Fatigue
Dynamic fatigue testing mechanical testing of the proposed Highness Implant System was performed in accordance with ISO 14801:2016, "Dentistry – Implants – Dynamic loading test for endosseous dental implants", and FDA guidance on "Root-form Endosseous Dental Implants and Endosseous Dental Abutments – Class II Special Controls Guidance Document for Industry and FDA Staff". The test articles were able to withstand 5,000,000 cycles without failure under substantially equivalent loading to the cited primary predicate device cleared under K182448.
SLA Surface Treatment
The Highness Implant System utilizes an SLA (Sand-blasted, Large grit, Acid-etched) surface treatment for its fixtures. Cleaning validation and SEM/EDS (Scanning Electron Microscopy/Energy Dispersive X-ray Spectroscopy) analysis were performed on the proposed device to ensure the removal of any particles or chemicals used during the process. The SEM/EDS analysis confirms that no elements other than titanium were found on the surface of the implant.
Biocompatibility
Biocompatibility classification is based on the FDA Guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process."
The subject devices are classified as the implant medical devices, tissue/bone, long-term exposure (>30 days).
The subject devices have fulfilled all testing required per ISO 7405:2018, "Dentistry -Evaluation of biocompatibility of medical devices used in dentistry", ISO 10993-1:2018, "Biological evaluation of medical devices – Part 1: Evaluation and testing" and the FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Cytotoxicity testing was conducted as per ISO 10993-5:2019, "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity". Cytotoxicity testing was conducted as per ISO 10993-5:2009, "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity" .
Sterilization and Shelf Life
Similar to the Predicate Devices, the Highness Implant System is packaged in an aluminum pouch and supplied sterile and non-sterile.
32
The non-sterile abutments used in the surgery must be sterilized by the end user, prior to use, as stated in the IFU. User moist heat sterilization for the subject non-sterile devices was conducted according to, ISO 17665-1:2006, "Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices", and ISO/TS 17665-2:2009, "Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1" and demonstrated a SAL of 10-6.
The sterile implants (fixtures), following to gamma sterilization and packaging were subjected to sterile barrier testing to validate a shelf life of 5 years according to ISO 11607-1:2019, "Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems" and ISO 11607-2:2019, "Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes" confirm the stability and effectiveness of the packaging of the sterilized product during the shelf life, by evaluating changes due to accelerated aging, according to ASTM F1980-21, "Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices".
For the sterile implants, gamma sterilization validation of the fixtures was performed in accordance with ISO 11137-1:2006, "Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices", ISO 11137-2:2013, "Sterilization of health care products – Radiation - Part 2: Establishing the sterilization dose", and ISO 11137-3:2017, "Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects of development, validation and routine control".
In addition, for sterile fixtures, bacterial endotoxin testing was performed on sterile devices in accordance with ANSI/AAMI ST72:2019, "Bacterial Endotoxins - Test Methods, Routine Monitoring, And Alternatives To Batch Testing" using the Limulus Amebocyte Lysate (LAL) pyrogen test method at a test limit of 20 EU/device.
A non-clinical worst-case MRI review was performed to evaluate the subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Maqnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, abutments, and fixation screws) and material composition. The rationale addressed parameters according to the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
33
X. CLINICAL TESTS
This 510(k) does not include data from clinical tests.
XI. CONCLUSIONS
The above information supports that the Highness Implant System is as safe and effective as the predicate devices. Although there are minor design differences between the subject and predicate devices, the review supports that these differences do not raise new questions of safety and effectiveness. Therefore, it is concluded that the Highness Implant System is substantially equivalent to the Predicate Devices.