(373 days)
No
The summary describes a standard dental implant system and its components, focusing on materials, mechanical properties, and biocompatibility. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations," which describes a direct medical treatment or intervention.
No
The device is an implant system used for supporting dental restorations, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of titanium (SF Fixtures, Cover Screw, Abutment, Abutment Screw) and the performance studies detail bench tests for mechanical performance, surface analysis, sterilization, and biocompatibility, all indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a dental implant system used for supporting restorations in the mouth. This is a surgical/implantable device, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the physical components of a dental implant system (fixtures, cover screw, abutment, etc.). This aligns with a medical device used for structural support, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the 8plant Implant System is a medical device, specifically a dental implant system, and not an IVD.
N/A
Intended Use / Indications for Use
8plant Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implant bodies with a diameter of 5mm or more are intended to be used in the molar region.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
8plant Implant System consists of SF Fixtures, Cover Screw, Abutment, and Abutment Screw.
- 8plant Implant System (SF Fixtures and Cover Screw)
This titanium dental implant features a SLA (Sandblasted with Large-grit and Acid-etched) surface with the alveolar bone and is designed to support single or multiple-unit restorations in partially or fully edentulous patients. It is secured to the upper structure using an internal hex fastening system. - 8plant Abutment System (Abutment and Abutment Screw)
8plant Abutment System is compatible with the SF Fixtures. 8plant Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. The 8plant Abutment System consists of the following;
- Healing Abutment: Healing is used during the healing period prior to restorations and maintain the shape of the gum.
- Rigid Abutment: It is a one-body product that consists of a support column and a screw integrally and the implant fixture and the 11° taper angle body taper face meet and are used
- Locator Abutment: Locator Abutment is a product that is located inside and acts as a support when manufacturing Overdenture through an implant fixture.
- Transfer Abutment: It is an abutment used when manufacturing screw retaining prosthesis in multiple cases.
- Angled Abutment: It is an abutment used when manufacturing screw retaining prosthesis in multiple cases.
- Temporary Abutment: Temporary Abutment is used by removing the healing abutment as an abutment for making temporary prostheses.
- Abutment Screw: It is used to fix the abutment to the fixture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae, molar region
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)
Bench tests were conducted to verify that the subject device met all design specifications as was substantially Equivalent (SE) to the predicate device.
- Mechanical Performance: Fatigue testing for 8plant Implant system was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and "SO 14001:2016 Dentistry - Fatigue test for Endosseous dental implants" under the worst case scenario.
- Surface Analysis: Surface modification testing, utilizing EDS and SEM evaluations was conducted across multiple lots to consistency and appropriateness of the S.L.A. treated implant surface according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
- Sterilization, Shelf-life and Packaging for Sterile Product: Gamma sterilization validation according to ISO 11137-1: 2006+A2:2018, ISO 11137-2:2013 and ISO 11137-3:2017; End User Sterilization Validation according to ISO 11138-1:2017. ISO 17665-1:2006. ISO 17665-2:2009. ISO 11737-1:2018 and ISO 11737-2:2019; Real time aging test according to ASTM F88, ASTM F1929.
- MR Environment Condition: Non-clinical worst-case MR review was performed to evaluate device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfin, and Sunder Rajan." 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 (al compatible implant bodies, abutments, and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetically including magnetically induced displacement force and torque.
- Bacterial Endotoxin: The subject device will not be labeled as "non-pyrogenic", and the endotoxin testing will be the subject device with the testing limit of below 0.5 EU/mL in accordance with the USP "Bacterial Endotoxins Test.
- Biocompatibility: Biocompatibility evaluations according to ISO 10993-1 and Biocompatibility according to ISO 10993-12.
The results of these tests have met the standards and demonstrated the substantial equivalence with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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, there 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
HOOWON EDI Co., Ltd % Sanglok Lee Manager Wise Company Inc. #507, #508, 166 Gasan digital 2-ro, Geumcheon-gu Seoul. Seoul 08503 REPUBLIC OF KOREA
May 24, 2024
Re: K231426
Trade/Device Name: 8plant Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 24, 2024 Received: April 24, 2024
Dear Sanglok Lee:
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.
1
2
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" (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 QS 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.
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.
2
For comprehensive regulatory information about medical devices and radiation-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).
Sincerely,
Andrew I. Steen -S
Andrew I. 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
Indications for Use
510(k) Number (if known)
Device Name 8plant Implant System
Indications for Use (Describe)
8plant Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implant bodies with a diameter of 5mm or more are intended to be used in the molar region.
| 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
510(k) Summary
Date revised: May 24, 2024
01. Applicant / Submitter
HOOWON EDI Co., Ltd 20-13, Seogimhaesandan-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea, 50967 TEL: +82 51 714 7240 Email: who1edi@gmail.com
02. Submission Correspondent
Sanglok, Lee Wise COMPANY Inc. #1107, #1108, 204 Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: +82 2 831 3615 Email: info@wisecompany.org
03. Proposed Device Identification
Trade Name: 8plant Implant system Classification Name: Implant, Endosseous, Root-Form Common Name: Endosseous Dental Implant Device Class: Class II Requlation Number: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA Review Panel: Dental
04. Indication for use
8plant Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implant bodies with a diameter of 5mm or more are intended to be used in the molar region.
05. Predicate Device Identification
Primary Predicate Device
| K Number | Manufacturer | Trade Name |
|---|---|---|
| K211090 | Izenimplant Co., Ltd. | ZENEX Implant System |
Reference Devices
| K Number | Manufacturer | Trade Name |
|---|---|---|
| K122231 | MegaGen Implant Co., Ltd. | Xpeed AnyRidge Internal Implant System |
| K210134 | Dentis Co., Ltd. | Dentis s-Clean s-Line |
| K210161 | MegaGen Implant Co., Ltd. | AnyOne Onestage Implant System |
5
06. Device Description
8plant Implant System consists of SF Fixtures, Cover Screw, Abutment, and Abutment Screw.
-
- 8plant Implant System (SF Fixtures and Cover Screw)
This titanium dental implant features a SLA (Sandblasted with Large-grit and Acid-etched) surface with the alveolar bone and is designed to support single or multiple-unit restorations in partially or fully edentulous patients. It is secured to the upper structure using an internal hex fastening system.
- 8plant Implant System (SF Fixtures and Cover Screw)
2) 8plant Abutment System (Abutment and Abutment Screw)
8plant Abutment System is compatible with the SF Fixtures. 8plant Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. The 8plant Abutment System consists of the following;
| Healing Abutment | Healing is used during the healing period prior to restorations and maintain the
shape of the gum. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Rigid Abutment | It is a one-body product that consists of a support column and a screw integrally
and the implant fixture and the 11° taper angle body taper face meet and are used |
| Locator Abutment | Locator Abutment is a product that is located inside and acts as a support when
manufacturing Overdenture through an implant fixture. |
| Transfer Abutment | It is an abutment used when manufacturing screw retaining prosthesis in multiple
cases. |
| Angled Abutment | It is an abutment used when manufacturing screw retaining prosthesis in multiple
cases. |
| Temporary Abutment | Temporary Abutment is used by removing the healing abutment as an abutment for
making temporary prostheses. |
| Abutment Screw | It is used to fix the abutment to the fixture. |
6
7. Substantial Equivalence Comparison
Dental Implant System has the same intended uses, principle of operation and similar technicality as predicate device and reference devices.
1) Fixture and Cover Screw
1-1) Fixture
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Manufacturer | HOOWON EDI Co., Ltd. | Izenimplant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Device Name | 8palnt Implant System | ZENEX Implant System | Xpeed AnyRidge Internal Implant System |
| 510(k) Number | K231426 | K211090 | K122231 |
| Product Code / | DZE / 21CFR 872.3640 | DZE / 21CFR 872.3640 | DZE / 21CFR 872.3640 |
| Regulation No. | |||
| Classification | Class II | Class II | Class II |
| Indications for Use | 8palnt Implant System is indicated for use | ||
| in partially or fully edentulous mandibles | |||
| and maxillae, in support of single or | |||
| multiple unit restorations including; | |||
| cemented retained, screw retained, or | |||
| overdenture restorations, and final or | |||
| temporary abutment support for fixed | |||
| bridgework. It is intended for delayed | |||
| loading. Implant bodies with a diameter of | |||
| 5mm or more are intended to be used in | |||
| the molar region. | ZENEX Implant System is indicated for use in | ||
| partially or fully edentulous mandibles and | |||
| maxillae, in support of single or multiple unit | |||
| restorations including; cemented retained, | |||
| screw retained, or overdenture restorations, | |||
| and final or temporary abutment support for | |||
| fixed bridgework. It is intended for delayed | |||
| loading. Wide Fixture System is intended to be | |||
| used in the molar region. | The Xpeed AnyRidge 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 Ø | |||
| 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. | |||
| Structure | - Internal Hex connected |
- Submerged Fixture
- Straight/Taper body shape | - Internal Hex connected
- Submerged Fixture
- Straight/Taper body shape | - Internal Hex connected
- Submerged Fixture
- Straight/Taper body shape |
| Body Diameter(Ø)
and Length (mm) | Ø3.75 x L 8.5, 10, 11.5, 13
Ø4.25 x L7, 8.5, 10, 11.5, 13
Ø4.6 x L7, 8.5, 10, 11.5, 13
Ø5.05 x L7, 8.5, 10, 11.5, 13
Ø5.6 x L7, 8.5, 10, 11.5, 13
Ø6.2 x L7, 8.5, 10, 11.5, 13
Ø7.1 x L7, 8.5, 10, 11.5, 13 | Mini
Ø 3.75 x L8.5, 10, 11.5, 13, 15
Regular
Ø 4.25 x L7, 8.5, 10, 11.5, 13,15
Ø 4.6 x L7, 8.5, 10, 11.5, 13, 15
Wide
Ø 5.05 x L7, 8.5, 10, 11.5, 13, 15
Ø 5.4 x L7, 8.5, 10, 11.5, 13
Ø 5.9 x L7, 8.5, 10, 11.5, 13 | Normal thread
Ø4.0 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø4.4 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø4.9 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø5.4 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø5.9 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Deep thread
Ø6.4 X 7.9, 9.4, 10.9, 12.4, 14.4
Ø6.9 X 7.9, 9.4, 10.9, 12.4, 14.4 |
7
| | | Ø 6.75 x L7, 8.5, 10, 11.5, 13 | Ø7.4 X 7.9, 9.4, 10.9, 12.4, 14.4
Ø7.9 X 7.9, 9.4, 10.9, 12.4, 14.4
Ø8.4 X 7.9, 9.4, 10.9, 12.4, 14.4 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------|
| | | | |
| Material | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) |
| Surface Treatment | Sandblasted and acid-etched | Sandblasted and acid-etched | Sandblasted and acid-etched |
| Sterilization | Gamma | Radiation | Radiation |
| Shelf life | 2 years | 5 years | 5 years |
| Similarities | The subject device has the same device characteristics with the predicate device such as diameters, length, intended use, material, principle
of operation, connection design, design, structure and sterilization method. | | |
| Differences | The diameter of the subject device includes Ø 7.1 that is slightly bigger than the primary predicate. To support this difference, K122231 is
added as a reference device to support the difference in diameter.
As the subject device doesn't categorize the fixture size into 'Mini, Regular, and Wide' like the predicate device, we have removed the phrase
related to the Wide Fixture System and revised it as follows: Implant bodies with a diameter of 5mm or more are intended to be used in the
molar region. | | |
1-2) Cover Screw
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Manufacturer | HOOWON EDI Co., Ltd. | Izenimplant Co., Ltd. | |
| Device Name | 8paint Implant System | ZENEX Implant System | |
| 510(k) Number | K231426 | K211090 | |
| Product Code / Regulation No. | DZE / 21CFR 872.3640 | DZE / 21CFR 872.3640 | |
| Classification | Class II | Class II | |
| Design | |||
| Connection Type | Non-Hex | Non-Hex | |
| Dimension | D(ø) | 3.1 | |
| 3.58 | 3.0 ~ 3.9 | ||
| Length(mm) | 5.1 ~ 5.9 | 5 ~ 7.3 | |
| Angle(°) | 0 | 0 | |
| Material | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) | |
| Surface Treatment | No Treatment | No Treatment |
8
K231426
| Sterilization | End User Sterilization | Gamma |
|---|---|---|
| Shelf life | Non-shelf Life | 5 years |
| Similarities | The subject device has the same device characteristics with the predicate device such as diameters, length, intended use, material, principle of operation, connection design, design, structure and surface treatment method. | |
| Differences | The subject device's sterilization is End User Sterilization, which is different from the predictive Device. Sterilization validation has been conducted to support this difference. |
2) Abutment and Abutment Screw
2-1) Healing Abutment
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Manufacturer | HOOWON EDI Co., Ltd. | Izenimplant Co., Ltd. | |
| Device Name | 8palnt Implant System | ZENEX Implant System | |
| 510(k) Number | K231426 | K211090 | |
| Product Code / Regulation No. | DZE / 21CFR 872.3640 | DZE / 21CFR 872.3640 | |
| Classification | Class II | Class II | |
| Design | Image: Subject Device Design | Image: Predicate Device Design | |
| Connection Type | Non-Hex | Non-Hex | |
| D(ø) | 4.3,4.8,5.3,5.8,6.3,7.3,8.3 | 4.3 ~ 9.0 | |
| Dimension | G/H(mm) | 1.0 ~ 12.0 | 2.0 ~ 9.0 |
| Angle(°) | 0 | 0 | |
| Material | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) | |
| Surface Treatment | No Treatment | No Treatment | |
| Sterilization | End User Sterilization | Gamma | |
| Shelf life | Non-shelf Life | 5years | |
| Similarities | The subject device has the same device characteristics with the predicate device such as intended use, material, connection | ||
| design, design, structure and surface treatment method. | |||
| Differences | G/H of subject device is slightly larger than the Predictive Device. This discrepancy is not critical to the device. | ||
| The subject device's sterilization is End User Sterilization, which is different from the predictive Device. Sterilization validation | |||
| has been conducted to support this difference. |
9
K231426
2-2) Rigid Abutment
| Subject Device | Reference Device | ||
|---|---|---|---|
| Manufacturer | HOOWON EDI Co., Ltd. | Dentis Co., Ltd. | |
| Device Name | 8palnt Implant System | Dentis s-Clean s-Line | |
| 510(k) Number | K231426 | K210134 | |
| Product Code / Regulation No. | DZE / 21CFR 872.3640 | DZE / 21CFR 872.3640 | |
| Classification | Class II | Class II | |
| Design | |||
| Connection Type | Non-Hex | Non-Hex | |
| D(ø) | 4.0~7.0 | 4.5~6.5 | |
| Dimension | P/H(mm) | 4.0,5.5,7.0 | - |
| Angle(°) | 0 | 0 | |
| Material | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) | |
| Surface Treatment | No Treatment | No Treatment | |
| Sterilization | End User Sterilization | End User Sterilization | |
| Similarities | The subject device has the same device characteristics with the predicate device such as diameters, Length, intended use, | ||
| material, principle of operation, connection design, design, structure, surface treatment and sterilization method. | |||
| Differences | The subject's P/H contains P/Hs that are not supported by the reference device, K210134. This discrepancy is not critical to the | ||
| device. |
2-3) Locator Abutment
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | HOOWON EDI Co., Ltd. | MegaGen Implant Co., Ltd. |
| Device Name | 8palnt Implant System | AnyOne Onestage Implant System |
| 510(k) Number | K231426 | K210161 |
| Product Code / Regulation No. | DZE / 21CFR 872.3640 | DZE / 21CFR 872.3640 |
| Classification | Class II | Class II |
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| Design | Image: Dental implant | Image: Dental implant | |
|---|---|---|---|
| Connection Type | Non-Hex | Non-Hex | |
| Dimension | D(ø) | 3.87,4.0 | 3.89 |
| G/H(mm) | 0.84~5.84 | 0.3,0.8,1.8,2.8,3.8,4.8,5.8,6.8 | |
| Angle(°) | 0 | Up to 20° | |
| Material | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) | |
| Surface Treatment | No Treatment | Partial TiN coated | |
| Sterilization | End User Sterilization | Non-Sterile | |
| Similarities | The subject device has the same device characteristics with the predicate device such as diameters, length, intended use, | ||
| material, principle of operation, connection design, design, structure and method. | |||
| Differences | The diameter of the subject device is slightly larger than that of the reference device, K210161. This difference does not affect | ||
| the basic functionality of the device. Sterilization validation has been conducted. |
2-4) Transfer Abutment
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Manufacturer | HOOWON EDI Co., Ltd. | Izenimplant Co., Ltd. | Dentis Co., Ltd. |
| Device Name | 8palnt Implant System | Cemented Abutment | Dentis s-Clean s-Line |
| 510(k) Number | K231426 | K211090 | K210134 |
| Product Code / Regulation No. | DZE / 21CFR 872.3640 | DZE / 21CFR 872.3640 | DZE / 21CFR 872.3640 |
| Classification | Class II | Class II | Class II |
| Design | Image: Gray dental implant | Image: Gold dental implant | Image: Gray dental implant |
| Connection Type | Hex | Hex | Hex |
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| Dimension | D(ø) | 4.0,4.5,5.0,5.5,6.0,6.5,7.0 | 4.5 ~ 6.5 | 4.5, 5.5, 6.5 |
|---|---|---|---|---|
| P/H(mm) | 4.0,5.5,7.0 | 4.0~7.0 | - | |
| Angle(°) | 0 | 0 | 0 | |
| Material | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) | |
| Surface Treatment | No Treatment | Partial TiN coated in upper | No Treatment | |
| Sterilization | End User Sterilization | Non-Sterile | End User Sterilization | |
| Similarities | The subject device has the same device characteristics with the predicate device such as diameters, length, intended use, material, principle of operation, connection design, design, structure and method. | |||
| Differences | The diameters of the subject device include Ø 4.0 and Ø 7.0 which are slightly smaller or larger than the predicate device. This difference does not affect the basic functionality of the device. Sterilization validation has been conducted. |
2-5) Angled Abutment
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Manufacturer | HOOWON EDI Co., Ltd. | Izenimplant Co., Ltd. | |
| Device Name | 8palnt Implant System | Angled Abutment | |
| 510(k) Number | K231426 | K211090 | |
| Product Code / Regulation No. | DZE / 21CFR 872.3640 | DZE / 21CFR 872.3640 | |
| Classification | Class II | Class II | |
| Design | Image: Subject Device Design | Image: Predicate Device Design | |
| Connection Type | Hex | Hex, Non-Hex | |
| D(ø) | 4.0,4.5,5.0,6.0 | 4.5, 5.5, 6.5 | |
| Dimension | G/H(mm) | 0.8,1.8,2.8,3.8 | 2.8, 3.8 |
| Angle(°) | 17 | 15, 25 | |
| Material | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) | |
| Surface Treatment | No Treatment | Partial TiN coating | |
| Sterilization | End User Sterilization | Non-Sterile | |
| Similarities | The subject device has the same device characteristics with the predicate device such as diameters, length, intended use, material, principle of operation, connection design, design, structure and sterilization method. | ||
| Differences | The diameter of the subject contains Ø4.0, slightly smaller than the reference device, K211090 This is discrepancy is not critical to |
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the device. Sterilization validation has been conducted.
2-6) Temporary Abutment
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Manufacturer | HOOWON EDI Co., Ltd. | Izenimplant Co., Ltd. | |
| Device Name | 8palnt Implant System | ZENEX Implant System | |
| 510(k) Number | K231426 | K211090 | |
| Product Code / Regulation No. | DZE / 21CFR 872.3640 | DZE / 21CFR 872.3640 | |
| Classification | Class II | Class II | |
| Design | Image: Subject Device Design | Image: Predicate Device Design | |
| Connection Type | Hex | Hex, Non-Hex | |
| D(ø) | 4.0, 4.6 | 4.0,4.5 | |
| Dimension | P/H(mm) | 10 | 10 |
| Angle(°) | 0 | 0 | |
| Material | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) | |
| Surface Treatment | No Treatment | Non-Coating | |
| Sterilization | End User Sterilization | Non-Sterile | |
| Similarities | The subject device has the same device characteristics with the predicate device such as diameters, length, intended use, | ||
| material, principle of operation, connection design, structure and method. | |||
| Differences | The diameter of the subject is slightly larger than that of the predict Device. This difference does not affect the basic | ||
| functionality of the device. Sterilization validation has been conducted. |
2-7) Abutment Screw
| Subject Device | Reference Device | |
|---|---|---|
| Manufacturer | HOOWON EDI Co., Ltd. | Dentis Co., Ltd. |
| Device Name | 8paInt Implant System | Dentis s-Clean s-Line |
| 510(k) Number | K231426 | K210134 |
| Product Code / Requlation No. | DZE / 21CFR 872.3640 | DZE / 21CFR 872.3640 |
| Classification | Class II | Class II |
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| Design | |||
|---|---|---|---|
| Connection Type | Hex | Hex | |
| Dimension | D(ø) | 2.1,2.2,2.3,2.5,2.9 | 2.32 |
| Length(mm) | 3.75,8.0,8.35,10.2 | 9.4 | |
| Angle(°) | 0 | 0 | |
| Material | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) | |
| Surface Treatment | No Treatment | Non-Coating | |
| Sterilization | End User Sterilization | End User Sterilization | |
| Similarities | The Subject device has the same device characteristics with the predicate device such as diameters, length, intended use, | ||
| material, principle of operation, connection design, design, structure, surface treatment and sterilization method. | |||
| Differences | The diameter of the subject device includes Ø 2.5,2.9 that is slightly bigger than the reference device, K210134. This | ||
| discrepancy is not critical to the device. |
08. Non-clinical Test
Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The results of the below tests have met the standards and demonstrated the substantial equivalence with the predicate device. The test results demonstrated that the subject device complies with the following standards:
· Mechanical Performance
- Fatigue testing for 8plant Implant system was conding to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseus Dental Implants and "SO 14001:2016 Dentisty - Fatigue test for Endosseous dental implants" under the worst case scenario.
· Surface Analysis
Surface modification testing, utilizing EDS and SEM evaluations was conducted across multiple lots to consistency and appropriateness of the S.L.A. treated implant surface according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
· Sterilization, Shelf-life and Packaqing for Sterile Product
- Gamma sterilization validation according to ISO 11137-1: 2006+A2:2018, ISO 11137-2:2013 and ISO 11137-3:2017
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K231426
-
End User Sterilization Validation according to ISO 11138-1:2017. ISO 17665-1:2006. ISO 17665-2:2009. ISO 11737-1:2018 and ISO 11737-2:2019
-
Real time aging test according to ASTM F88, ASTM F1929
= MR Environment Condition
Non-clinical worst-case MR review was performed to evice components in the MRI environment using scientific rationale and published iterature (e.g., Woods, Terry O., Jana G. Delfin, and Sunder Rajan." Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Eraluation 49.2 (2019): 783-795), based on the entire (al compatible implant bodies, abutments, and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetically including magnetically induced displacement force and torque.
· Bacterial Endotoxin
The subject device will not be labeled as "non-pyrogenc", and the endotoxin testing will be the subject device with the testing limit of below 0.5 EU/mL in accordance with the USP "Bacterial Endotoxins Test.
· Biocompatibility
Biocompatibility evaluations according to ISO 10993-1 and Biocompatibility according to ISO 10993-12.
09. Substantial Equivalence Conclusion
The subject device has the same indications for use and technological characteristics, as the above identified predicate device for each difference was presented, similarities and differences were addressed.
Based upon the comparison and information described above, HOOWON EDI Co., Ltd. has concluded that the Splantially equivalent to the discussed primary predicate and reference devices.