(266 days)
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 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 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.
This document, K240383, is a 510(k) Premarket Notification for the Highness Implant System. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving the device meets specific acceptance criteria related to clinical performance or AI/software.
Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets such criteria in the context of clinical effectiveness, AI performance, or human reader improvement. This document is a regulatory submission for a medical device (dental implants) and, as explicitly stated in Section X, it does not include data from clinical tests.
Therefore, I cannot provide answers to most of your requested points as they pertain to clinical studies, AI performance, or multi-reader multi-case studies, which are not present in this regulatory submission.
However, I can extract information related to non-clinical testing which demonstrates the device meets certain performance standards (acceptance criteria) for the device itself, not for an AI component or clinical outcomes.
Here's what can be extracted from the document regarding non-clinical performance:
1. A table of acceptance criteria and the reported device performance
The document provides performance data in relation to industry standards and guidance, which serve as the acceptance criteria for these non-clinical tests.
| Acceptance Criterion (Standard / Guidance) | Reported Device Performance |
|---|---|
| Fatigue: ISO 14801:2016 and FDA guidance on "Root-form Endosseous Dental Implants and Endosseous Dental Abutments – Class II Special Controls Guidance Document" (specifically, ability to withstand 5,000,000 cycles without failure under equivalent loading to primary predicate). | The test articles (Highness Implant System) were able to withstand 5,000,000 cycles without failure under substantially equivalent loading to the cited primary predicate device (K182448). |
| SLA Surface Treatment: Removal of particles/chemicals, no elements other than titanium on surface. | Cleaning validation and SEM/EDS (Scanning Electron Microscopy/Energy Dispersive X-ray Spectroscopy) analysis were performed. The SEM/EDS analysis confirms that no elements other than titanium were found on the surface of the implant. |
| Biocompatibility: ISO 10993-1:2018, ISO 7405:2018, ISO 10993-5:2019/2009, and FDA guidance. | The device fulfilled all required testing per specified ISO standards and FDA guidance. Cytotoxicity testing was conducted as per ISO 10993-5. (No specific numerical performance metric is given beyond "fulfilled all testing" and "was conducted," implying successful completion against the standard's criteria). |
| Sterilization (Non-sterile abutments): ISO 17665-1:2006, ISO/TS 17665-2:2009. | Demonstrated a Sterility Assurance Level (SAL) of 10^-6. |
| Sterilization (Sterile implants/fixtures): ISO 11137-1:2006, -2:2013, -3:2017. | Gamma sterilization validation was performed in accordance with these standards. (No specific numerical performance metric is given beyond "was performed," implying successful validation). |
| Shelf Life (Sterile implants/fixtures packaging): ISO 11607-1:2019, -2:2019, ASTM F1980-21. | Sterile barrier testing confirms the stability and effectiveness of the packaging for a shelf life of 5 years by evaluating changes due to accelerated aging. (Implies satisfactory performance against these standards). |
| Bacterial Endotoxin Testing (Sterile implants): ANSI/AAMI ST72:2019. | Performed at a test limit of 20 EU/device. (Implies meeting the limit, as no negative result is stated). |
| MRI Safety (Non-clinical worst-case review): FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." | Reviewed using scientific rationale and published literature. The rationale addressed parameters including magnetically induced displacement force and torque based on all compatible components and material composition. (Implies satisfactory addressing of these safety concerns through a non-clinical review). |
Points that cannot be addressed from the document:
- 2. Sample sized used for the test set and the data provenance: Not applicable for non-clinical tests in the context of user evaluation or clinical effectiveness. The numbers of devices tested for fatigue, biocompatibility, and sterilization validation are not specified, only that the tests were performed "in accordance with" standards. Data provenance (country, retrospective/prospective) is typically for clinical data, which is absent.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this refers to establishing ground truth for perception/interpretation tasks, or clinical endpoints, neither of which are part of this 510(k) submission.
- 4. Adjudication method: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as there's no AI component or clinical study.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for non-clinical material and mechanical tests. The "ground truth" here is the physical and material properties meeting specified engineering and biological standards.
- 8. The sample size for the training set: Not applicable, no AI/training set.
- 9. How the ground truth for the training set was established: Not applicable, no AI/training set.
{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).
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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 AngledAbutment | 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.
<Substantial Equivalence to Predicate Devices Table – Fixture>
| 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 implantsImage: Subject Device Implant | Root-form endosseous dental implantsImage: Primary Predicate Device Implant | Root-form endosseous dental implantsImage: 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 mmHS-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); and4.8, 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}------------------------------------------------
<Substantial Equivalence to Predicate Devices Table – Abutment>
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 SystemEndosseous Dental ImplantSystem | Octa 1 SystemEndosseous Dental ImplantSystem | Endosseous Dental ImplantSystem | 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 isdesigned to be surgicallyplaced in the maxillary ormandibular arches for thepurpose of providing prostheticsupport for dental restorations(crowns, bridges, andoverdentures) in partially orfully edentulous individuals. Itis used to the restore thepatient's chewing function.Implants with diameter lessthan ø5.5mm are intended forimmediate loading when goodprimary stability is achievedand with appropriate occlusalloading. Larger implants arededicated to the molar regionand are indicated for delayedloading.The Multi-Unit Abutments are | The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in themaxillary or mandibular archesfor the purpose of providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore a patient'schewing function in thefollowing situations and withthe clinical protocols:-Delayed loading,-Immediate loading when goodprimary stability is achievedand with appropriate occlusalloading.Larger implants are dedicatedfor the molar region. | The Link Abutment for CEREC istitanium alloy abutmentsplaced onto HIOSSEN dentalimplants to provide support forcustomized prostheticrestorations.Link Abutment for CEREC isindicated for screw-retainedsingle tooth or cement-retained single tooth andbridge restorations. - Linkabutment for CERECAll digitally designed copingsand/or crowns for use with theLink abutment for CEREC is tobe scanned using Sirona CERECAC or CEREC AF or CEREC AI,designed using Sirona inLabsoftware (Version 3.65) orSirona CEREC Software (Version4.2) and manufactured using a | Similar: Indications for use of thesubject device is slightly differentfrom the primary predicate inphrase but fundamental indicationfrom the reference devices is theidentical. |
| SUBJECT Device | Primary PREDICATE Device(K182448) | REFERENCE Device (K160519) | Significant Difference | |
| Manufacturer | highness Co., Ltd.intended for multi-unitrestorations only and can beused up to 25 degrees whenconnecting cylinder. | MegaGen Implant Co., Ltd. | OSSTEM Implant Co., LtdSirona CEREC or inLab MC X orMC XL milling unit. CAD/CAMmanufacturing/milling occursat dental laboratories per thedesign limitations of the SironaCEREC. | – |
| 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 sterilizationprior to use | Non-sterile; Steam sterilizationprior to use | Non-sterile; Steam sterilizationprior to use | Identical |
| Single Use | Yes | Yes | Yes | Identical |
| Restoration type | Single & Multi | Single & Multi | Single & Multi | Identical |
| Biocompatibility | Biocompatible in accordancewith ISO 10993-1 | Biocompatible in accordancewith ISO 10993-1 | Biocompatible in accordancewith ISO 10993-1- | Identical |
| Principle of Operation | This product is a superstructurewhich is connects with thefixtures using the AbutmentScrew. It replaces the functions | This product is a superstructurewhich is connects with thefixtures using the AbutmentScrew. It replaces the functions | This product is a superstructurewhich is connects with thefixtures using the AbutmentScrew. 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 dentalabutment. | of the missing teeth as a dentalabutment. | of the missing teeth as a dentalabutment. | ||
| SE | The subject device has the same intended use, material, principle of operation and similar design as the predicate device and re, andthere are slightly different dimensions. However, the abutment diameter and angulation range of the subject device is within the rangeof the predicate device. And the subject device has slightly different of post height and Cuff Height. However, this post height and gingivalrange 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 substantialequivalent. |
{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 | – |
| RegulationDescription | Endosseous Dental Implant System | Endosseous Dental Implant System | Identical |
| RegulationNumber | 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 DevicePrimary PREDICATE Device (K182448) | Significant Difference | ||
| Manufacturer | highness Co., Ltd.appropriate occlusal loading. Larger implants arededicated to the molar region and are indicated fordelayed loading.The Multi-Unit Abutments are intended for multi-unitrestorations only and can be used up to 25 degrees whenconnecting cylinder. | MegaGen Implant Co., Ltd.-Delayed loading,-Immediate loading when good primary stability isachieved 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 |
| Restorationtype | Single & Multi | Single & Multi | Identical |
| Biocompatibility | Biocompatible in accordance with ISO 10993-1 | Biocompatible in accordance with ISO 10993-1 | Identical |
| Principle ofOperation | This product is a superstructure which is connects withthe fixtures using the Abutment Screw. It replaces thefunctions of the missing teeth as a dental abutment. | This product is a superstructure which is connectswith the fixtures using the Abutment Screw. Itreplaces 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 HighnessImplant System | Octa Abutment For AnyRidgeOcta 1 System | Solid Abutment for ST InternalImplant System | – |
| Regulation Description | Endosseous Dental ImplantSystem | Endosseous Dental ImplantSystem | Endosseous Dental ImplantSystem | 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 isdesigned to be surgicallyplaced in the maxillary ormandibular arches for thepurpose of providing prostheticsupport for dental restorations(crowns, bridges, andoverdentures) in partially orfully edentulous individuals. Itis used to the restore the | The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in themaxillary or mandibular archesfor the purpose of providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore a patient's | The ST Internal Implant Systemis intended to be surgicallyplaced in the maxillary ormandibular arches for thepurpose providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals. Itis 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 lessthan ø5.5mm are intended forimmediate loading when goodprimary stability is achievedand with appropriate occlusalloading. Larger implants arededicated to the molar regionand are indicated for delayedloading.The Multi-Unit Abutments areintended for multi-unitrestorations only and can beused up to 25 degrees whenconnecting cylinder. | MegaGen Implant Co., Ltd.chewing function in thefollowing situations and withthe clinical protocols:-Delayed loading,-Immediate loading when goodprimary stability is achievedand with appropriate occlusalloading.Larger implants are dedicatedfor the molar region. | Megagen Implant Co. Ltd.chewing function. Smallerimplants (less than 6.0 mm) arededicated for immediateloading when good primarystability is achieved and withappropriate occlusal loading.Larger implants are dedicatedfor the molar region and areindicated 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 accordancewith ISO 10993-1 | Biocompatible in accordancewith ISO 10993-1 | Biocompatible in accordancewith ISO 10993-1 | Identical |
| Principle of Operation | This product is a superstructurewhich is connects with thefixtures using the AbutmentScrew. It replaces the functionsof the missing teeth as a dentalabutment. | This product is a superstructurewhich is connects with thefixtures using the AbutmentScrew. It replaces the functionsof the missing teeth as a dentalabutment. | This product is a superstructurewhich is connects with thefixtures using the AbutmentScrew. It replaces the functionsof the missing teeth as a dentalabutment. | Identical |
| SE | The subject device has the same intended use, material, principle of operation and similar design as the primary predicate, and thereare different dimensions. However, the abutment diameter, post height and Cuff Height range of the subject device is within the rangeof the reference device. These differences do not affect product's fundamental function. Also, the connection interface is different butboth 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 forHighness Implant System | Multi-unit Abutment For Multi-unit Abutment, Multi-unitAngled Abutment | Multi-unit Abutment For Multi-unit Abutment, Multi-unitAngled Abutment | – |
| Regulation Description | Endosseous Dental ImplantSystem | Endosseous Dental ImplantSystem | Endosseous Dental ImplantSystem | 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 sterilizationprior to use | Non-sterile; Steam sterilizationprior to use | Non-sterile; Steam sterilizationprior to use | Identical |
| Single Use | Yes | Yes | Yes | Identical |
| Restoration type | Multi | Single & Multi | Single & Multi | Identical |
| Biocompatibility | Biocompatible in accordancewith ISO 10993-1 | Biocompatible in accordancewith ISO 10993-1 | Biocompatible in accordancewith ISO 10993-1 | Identical |
| Principle of Operation | This product is a premanufacturedprosthetic component directlyconnected to the endosseousdental implant and is intended foruse as an aid in prostheticrehabilitation. | Multi-unit Abutment is apremanufactured prostheticcomponent directly connected tothe endosseous dental implantand is intended for use as an aid inprosthetic rehabilitation. | This product is a pre-manufacturedprosthetic component directly orindirectly connected to theendosseous dental implant usingits threaded part or screw for aidin 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 Octaand 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 lessthan ø5.5mm are intended forimmediate loading when goodprimary stability is achievedand with appropriate occlusalloading. Larger implants arededicated to the molar regionand are indicated for delayedloading.The Multi-Unit Abutments areintended for multi-unitrestorations only and can beused up to 25 degrees whenconnecting cylinder. | MegaGen Implant Co., Ltd.following situations and withthe clinical protocols:-Delayed loading,-Immediate loading when goodprimary stability is achievedand with appropriate occlusalloading.Larger implants are dedicatedfor 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 accordancewith ISO 10993-1 | Biocompatible in accordancewith ISO 10993-1 | Biocompatible in accordancewith ISO 10993-1 | Identical |
| Principle of Operation | Multi-unit Angled Abutment is apremanufactured prostheticcomponent directly connected tothe endosseous dental implantand is intended for use as an aid inprosthetic rehabilitation. | Multi-unit Angled Abutment is apremanufactured prostheticcomponent directly connected tothe endosseous dental implantand is intended for use as an aid inprosthetic rehabilitation. | This product is a pre-manufacturedprosthetic component directlyconnected to the endosseousdental implant using the screw andis intended for use as an aid inprosthetic rehabilitation. | Identical |
| SE | The subject device has the same intended use, material, principle of operation and similar design as the primary predicate, and thereare different dimensions. However, the abutment diameter, Cuff Height and angulation range of the subject device is within the rangeof the reference device. These differences do not affect product's fundamental function. Also, the connection interface is different butboth 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-unitAbutment Screw for HighnessImplant System | Multi-unit Abutment Screw ForAnyRidge Octa 1 ImplantSystem | Multi Angled Abutment Screw | - |
| Regulation Description | Endosseous Dental ImplantSystem | Endosseous Dental ImplantSystem | Endosseous Dental ImplantSystem | 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 tobe surgically placed in the maxillary ormandibular arches for the purpose ofproviding prosthetic support for dentalrestorations (crowns, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to the restore thepatient's chewing function. Implants withdiameter less than ø5.5mm are intended forimmediate loading when good primarystability is achieved and with appropriateocclusal loading. Larger implants arededicated to the molar region and areindicated for delayed loading.The Multi-Unit Abutments are intended formulti-unit restorations only and can be used | The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular arches for the purposeof providing prosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient'schewing function in the following situationsand with the clinical protocols:-Delayed loading,-Immediate loading when good primarystability is achieved and with appropriateocclusal loading.Larger implants are dedicated for the molarregion. | 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 conjunctionwith fixture to provide support for provisionalrestoration. | Temporary Abutment is used in conjunctionwith fixture to provide support for provisionalrestoration. | 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 isto meet each patient needs and does not raise an issue in performance or safety since the size difference is very minor; therefore, it issubstantial 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 areintended for multi-unitrestorations only and can beused up to 25 degrees whenconnecting 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 sterilizationprior to use | Non-sterile; Steam sterilizationprior 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 accordancewith ISO 10993-1 | Biocompatible in accordancewith ISO 10993-1 | Biocompatible in accordancewith ISO 10993-1 | Identical |
| Principle of Operation | The Healing Abutment isfastened into the female screwof dental implant and supportthe gingival shaping. | The Healing Abutment isfastened into the female screwof dental implant and supportthe gingival shaping. | The Healing Abutment isfastened into the female screwof dental implant and supportthe gingival shaping. | Identical |
| SE | The subject device has the same intended use, principle of operation, material, connection interface, and similar design as the predicatedevices, 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 raisean issue in performance or safety since the size difference is very minor. The other difference is in surface treatment, but we alreadypresented 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 ImplantSystem | Cover Screw For AnyRidge Octa 1Implant 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 isdesigned to be surgically placed in themaxillary or mandibular arches for thepurpose of providing prostheticsupport for dental restorations(crowns, bridges, and overdentures) inpartially or fully edentulous individuals.It is used to the restore the patient'schewing function. Implants withdiameter less than ø5.5mm areintended for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading.Larger implants are dedicated to the | The AnyRidge Octa 1 Implant System isintended to be surgically placed in themaxillary or mandibular arches for thepurpose of providing prostheticsupport for dental restorations (Crown,bridges, and overdentures) in partiallyor fully edentulous individuals. It isused to restore a patient's chewingfunction in the following situations andwith the clinical protocols:-Delayed loading,-Immediate loading when goodprimary stability is achieved and withappropriate 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 insurface treatment, but we already presented multiple predicate device for anodizing in the other component comparisoncharts. 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.
§ 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.