(87 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on material properties, sterilization, and mechanical testing.
Yes
The device is used to assist in the treatment of missing mandibular central and lateral incisors to restore chewing functions, which is a therapeutic purpose.
No.
The device is an implant system intended to restore chewing function by supporting dental prosthetic devices, rather than diagnosing a condition.
No
The device description explicitly states it consists of physical components (a one-piece implant and temporary cap made of CP Ti Grade 4 and Polyoxymethylene, respectively). The performance studies also focus on physical properties like fatigue, sterilization, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to support dental prosthetic devices to restore chewing function in patients with missing teeth. This is a therapeutic and restorative function, not a diagnostic one.
- Device Description: The device is a physical implant and temporary cap made of materials like titanium and polyoxymethylene. These are materials used for surgical implantation, not for analyzing samples from the human body.
- Performance Studies: The performance studies focus on mechanical properties (fatigue), sterilization, shelf-life, biocompatibility, and MR safety. These are all relevant to a surgically implanted device, not an IVD which would involve studies on analytical performance (sensitivity, specificity, etc.) using biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
In summary, the LL Implant System is a medical device used for surgical implantation and restoration of function, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The LL Implant System is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The LL Implant System consists of a one-piece implant and temporary cap.
The LL Mini Onebody Implant is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: submerged type, tapered body, sided cutting edge. The LL Temporary Cap is made Polyoxymethylene (ASTM F1855) without any surface treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandibular central and lateral incisors
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)
Non-Clinical Test Data
- Fatigue Testing according to ISO 14801:2016 .
- Gamma Sterilization Validation Test on LW Fixture according to ISO 11137-1, ISO 11137-2, . and ISO 11137-3 referenced in K223924 (LW Implant System)
- End User Sterilization Validation Test Report on LW Retraction Cap according to ISO 17665-1, and ISO 17665-2 referenced in K231079 (LW Retraction Cap)
- Shelf-Life Test on LW Fixture according to ASTM F1980 referenced in K223924 (LW Implant Svstem)
- Biocompatibility testing on LW Fixture according to ISO 10993-1:2018 referenced in K223924 . (LW Implant System)
- Biocompatibility testing on LW Retraction Cap according to ISO 10993-1:2018 referenced in K231079 (LW Retraction Cap)
- LAL endotoxin testing on LW Fixture according to USP 43, referenced in K223924 (LW Implant System)
- Surface Modification Information on LW Fixture referenced in K223924 (LW Implant System)
Surface Modification Information: The surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. The surface modification with SLA (sand-blasted, large-grit, acid-etched) was provided. To compare surface modification between the subject and predicate device, surface roughness, surface composition analysis, SEM imaging, and ICP analysis were provided, and it demonstrates substantial equivalence.
Gamma Sterilization Validation: For devices delivered in a sterile state, such as Implants, a sterility assurance level (SAL) of 10 has been validated in accordance with ISO 11137-1 "Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices". The validation took into account the worst-case scenario, and the results prove equivalence to the predicate device.
End User Sterilization Validation: The non-sterile abutments are intended to be sterilized by the end user. The recommended sterilization conditions have been validated through the end-user sterilization, following ISO 17665-1 "Sterilization of health care products - Moist heat - part 1: Requirements for the development. validation, and routine control of a sterilization process for medical devices", ISO 17665-2 "Sterlization of health care products – Moist heat – part 2: Guidance on the application of ISO 17665-1", and the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The validation considered the worst-case scenario, and the results demonstrated equivalence to the predicate device.
Biocompatibility Testing: Biocompatibility Testing was performed in accordance with ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" 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', Guidance for Industry and Food and Drug Administration Staff". Cytotoxicity testing was performed according to ISO 10993-5.
Shelf-life Testing: The devices provided in a sterile state underwent Shelf-life testing in accordance with ASTM F1980, "Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices". The worstcase scenario was tested, and the results demonstrated that the devices are equivalent to the predicate devices. The shelf-life for the Implant is 5 years, and throughout this time frame, the devices will function as intended without any degradation.
Fatigue Testing: To evaluate performance of the subject device, Dynamic Fatigue, and Static Compression Strength tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801:2016, "Dentistry – Implants – Dynamic fatigue test for endosseous dental implants" under the worst-case scenario. As a result, our dental implant system is expected to function properly for its intended use, which is to replace the patient's natural tooth and restore chewing function.
Bacterial Endotoxin Testing: To address the presence of bacterial endotoxins, the devices corresponding to implants should meet the pyrogen limit specifications as specified in the FDA guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" and USP "Medical Devices – Bacterial Endotoxin and Pyrogen Tests". Therefore, our dental implants were tested for bacterial endotoxin under USP "Bacterial Endotoxins Test", and USP "Medical Devices – Bacterial Endotoxin and Pyrogen Tests". The test results have met the acceptance criteria and demonstrated the substantial equivalence with the predicate device.
MR Safety: Non-clinical worst-case MRI review was performed to evaluate the subject devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 4 9.2 (2 01 9): 7 8 3-795), based on the entire system including all implants and abutments and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
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.
K170394, K112540, K223924, K231079, K182091
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.
Ossvis Co., Ltd. Woojin Lee Regulatory Affairs Specialist 38, Burim-ro 170beon-gil, Dongan-gu 6F, 7F and B1 Anyang-si, Gyeonggi-do 14055 REPUBLIC OF KOREA
November 7, 2024
Re: K242379
Trade/Device Name: LL Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 9, 2024 Received: August 12, 2024
Dear Woojin 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
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.
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 Rule"). 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-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.
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) K242379
Device Name LL Implant System
Indications for Use (Describe)
The LL Implant System is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.
| 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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510(K) Summary
Submitter Information
Ossvis Co., Ltd. Woo Jin Lee 6F, 7F and B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea Email: wjl316@huvitz.com Tel. +82-31-360-0082 Fax. +82-31-360-0058
Device Information
- Trade Name: LL Implant System
- Common Name: Endosseous Dental Implant ●
- . Classification Name: Implant, Endosseous, Root-Form
- Primary Product Code: DZE .
- . Secondary Product Code: NHA
- Panel: Dental
- . Regulation Number: 21 CFR 872.3640
- Device Class: Class II
- Date Prepared: October 16,2024
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
-
. K191201, EM SA Implant System by Hiossen, Inc.
Reference Device -
K170394, Kisses Mini by ACHIMHAI Medical Corporation ●
-
K112540, S-MiNi Implant System by Neobiotech Co., Ltd. ●
-
K223924, LW Implant System by Ossvis Co., Ltd. ●
-
K231079, LW Retraction Cap by Ossvis Co., Ltd.
-
K182091, Osstem Abutment System by OSSTEM IMPLANT Co., Ltd. ●
Indication for Use:
The LL Implant System is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.
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Device Description:
The LL Implant System consists of a one-piece implant and temporary cap.
The LL Mini Onebody Implant is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: submerged type, tapered body, sided cutting edge. The LL Temporary Cap is made Polyoxymethylene (ASTM F1855) without any surface treatment.
| No | Device Name | Dimension |
|---|---|---|
| 1 | LL Mini Onebody Implant | Ø 2.7, 3.1 (D) x 8.5, 10.0, 11.5, 13.0 mm (L) |
| 2 | LL Temporary Cap | Ø 4.0 (D) x 9.6 mm (L) |
The dimensions of subject devices are as following:
The below table outlines the information of intended uses and surface treatment:
| Device Name | Uses | Surface Treatment |
|---|---|---|
| LL Mini Onebody Implant | Implant is intended to replace the patient's | |
| natural tooth and restore chewing function. | SLA | |
| LL Temporary Cap | Used to protect the upper part of LL Mini | |
| Onebody Implant in the oral cavity | None |
The LL Mini Onebody Implant is provided sterile. And LL Temporary Cap is provided non-sterile, which are required to be sterilized by the end-user before use.
Materials:
- Dental Implant is fabricated from Pure titanium of ASTM F67
- Temporary Cap is fabricated from POM(Polyoxymethylene) of ASTM F1855 ●
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Ossvīs
Ossvis Co., Ltd. 6F, 7F and B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea
Summaries of Technological Characteristics & Substantial Equivalence Discussion
LL Implant System
| LL Mini Onebody Implant | ||||
|---|---|---|---|---|
| Subject Device | Predicate Device | Reference Device | Reference Device | |
| 510(k) # | K242379 | K191201 | K170394 | K112540 |
| Device Name | LL Implant System | EM SA Implant System | Kisses Mini | S-MiNi Implant System |
| Implant Name/Type | LL Mini Onebody Implant | Narrow Ridge Type | Post Type | Cement Type |
| Manufacturer | Ossvis Co., Ltd. | Hiossen, Inc. | Achimhai Medical Corporation | Neobiotech Co., Ltd. |
| Product Code | DZE | DZE | DZE | DZE |
| Regulation | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 |
| Appearance | Image: LL Mini Onebody Implant | Image: EM SA Implant System | Image: Kisses Mini | Image: S-MiNi Implant System |
| Indications for Use Statement | The LL Implant System is | |||
| intended to be use in the | ||||
| treatment of missing mandibular | ||||
| central and lateral incisors to | ||||
| support dental prosthetic devices, | ||||
| such as artificial teeth, in order to | ||||
| restore chewing function in | ||||
| partially edentulous patients. It is | ||||
| intended for single use only. It is | ||||
| intended for delayed loading. | The EM SA Implant System | |||
| (DENTURE) is intended to be | ||||
| place in the bone of the upper or | ||||
| lower jaw arches providing | ||||
| support to dental prosthetic | ||||
| devices, specifically for denture | ||||
| stabilization to restore a patient's | ||||
| chewing function. It is intended | ||||
| for single use only. | ||||
| The EM SA Implant (NARROW | ||||
| RIDGE) is intended to be use in | ||||
| the treatment of missing | ||||
| mandibular central and lateral | ||||
| incisors to support dental | ||||
| prosthetic devices, such as | ||||
| artificial teeth, in order to restore | ||||
| chewing function in partially | ||||
| edentulous patients. It is intended | The Kisses Mini is indicated for use | |||
| in partially or fully edentulous | ||||
| mandibles and maxilla, in support | ||||
| of single or multiple-unit | ||||
| restorations including; cemented | ||||
| retained, screw retained, or | ||||
| overdenture restorations, and | ||||
| terminal or intermediate abutment | ||||
| support for fixed bridgework. The | ||||
| Kisses Mini is for single and two | ||||
| stage surgical procedures. It is for | ||||
| delayed loading. | ||||
| The intended use of the 3.2 mm | ||||
| Internal Hex Fixture is limited to | ||||
| the replacement of maxillary lateral | ||||
| incisors and mandibular incisors. | ||||
| The intended use of the single-piece | ||||
| post type fixture is limited to the | The S-MiNi Implant System is | |||
| divided into two types: |
- Cement Type
The Cement type is indicated for
use in the treatment of missing
maxillary lateral incisors or the
mandibular central and lateral
incisors to serve as temporary
support prosthetic devices during
the healing phase of permanent
endosseous dental implant, such as
artificial teeth, in order to restore
chewing function in partially
edentulous patients. - Ball Type |
| | | | | |
| | for single use only. It is intended
for delayed loading. | | replacement of mandibular central
and lateral incisors.
The ball-type single-piece implant
is intended for stabilization and
retention of overdentures. | The Ball type is designed for use in
dental implant surgery. Ball type is
intended for use in partially or fully
edentulous mandibles and maxiliae
in support of overdentures. Ball
type implants are for temporary use
only. |
| | • Integrated Implant System (One
body) | • Integrated Implant System
(One body) | • Integrated Implant System
(One body) | • Integrated Implant System
(One body) |
| Structure | • Tapered & Straight body shape
• Threaded body design
• Cutting edge with self- tapping | • Tapered & Straight body shape
• Threaded body design
• Cutting edge with self- tapping | • Tapered & Straight body shape
• Threaded body design
• Cutting edge with self- tapping | • Tapered & Straight body shape
• Threaded body design
• Cutting edge with self -tapping |
| Diameter (Ø) | 2.7, 3.1 | 2.5, 3.0 | 2.8, 3.0 | 2.0, 2.5, 3.0, 3.5 |
| Length (mm) | 8.5, 10.0, 11.5, 13.0 | 8.5, 10.0, 11.5, 13.0, 15.0 | 8.0, 9.5, 11.0, 12.5, 14.5 | 7.0, 8.5, 10.0, 11.5, 13.0, 15.0 |
| Material | Pure Titanium Grade 4
(ASTM F67) | Ti 6Al 4V ELI
(ASTM F136) | Pure Titanium Grade 4
(ASTM F67) | Pure Titanium Grade 4
(ASTM F67) |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Surface treatment | SLA | SLA | SLA | RBM |
| Substantial Equivalence Discussion | | | | |
| The II Mini Onebody Implant has the same intended use, design features, surface treatment, and sterilization as the primary predicate K101201. Both devices feature a one- | | | | |
LL Mini Onebody Implant
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Ossvis Co., Ltd. 6F, 7F and B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea
110 - 22 min other intention and mich clearly, and on the man and mind may produced on one producer on the species the may predicate devices are the material and dimensions The prince is made of T-6A1-V EL and does not include diameters above 3.1 mm, whereas the subject de vice is made of Pure Titanium Grade 4. However, these differences are overed by the reference devices. Reference devices K170394 is made of Pare Titanium Grade 4 and undergoes SLA surface treation. Reference device K112540 offers a vider range of dimensions than the subject device, supporting substantial equivalence. Therefore, the subject device is considered substantially equivalent.
8
Ossvis Co., Ltd. 6F, 7F and B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea
Ossvīs
LL Temporary Cap
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| 510(k) # | K242379 | K231079 | K182091 |
| Device Name | LL Implant System | LW Retraction Cap | Osstem Abutment System |
| Abutment Name | LL Temporary Cap | LW Retraction Cap | Temporary Cap (Narrow Ridge) |
| Manufacturer | Ossvis Co., Ltd. | Ossvis Co., Ltd. | OSSTEM IMPLANT Co., Ltd. |
| Product Code | NHA | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: LL Temporary Cap | Image: LW Retraction Cap | Image: Temporary Cap (Narrow Ridge) |
| Intended Use | Used in the oral cavity to protect the upper part | ||
| of compatible one-piece implant from foreign | |||
| substances such as plaque. | Used in the oral cavity to protect compatible | ||
| abutments from foreign substances such as | |||
| plaque. | Used in the oral cavity to protect compatible | ||
| abutments from foreign substances such as | |||
| plaque. | |||
| Diameter (Ø) | 4.0 | 5.0, 6.0, 6.1, 6.7, 7.2, 7.7, 8.2, 8.7 | 4.0 |
| Length (mm) | 9.6 | 5.5, 7.0, 8.5 | 9.6 |
| Material | POM (Polyoxymethylene) | ||
| (ASTM F1855) | POM (Polyoxymethylene) | ||
| (ASTM F1855) | Poly Carbonate | ||
| Sterilization | N/A | N/A | N/A |
| Surface treatment | N/A | N/A | N/A |
| Substantial Equivalence Discussion | |||
| The LL Temporary Cap has the same indication for use, material, design feature, structure, surface treatment, and sterilization as the reference devices. | |||
| The difference between the subject and reference device(K231079) is dimensions. However, it is used temporarily in the oral cavity and the size is designed to fit its | |||
| compatible implant considering the intended use of the device. Also the dimensional difference is covered by the reference device(K182091). Therefore, we believe that the | |||
| difference does not raise any serious issues in performance or safety, and the subject device is substantial equivalence to the predicate device. |
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Non-Clinical Test Data
Below tests were performed on the subject device:
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Fatigue Testing according to ISO 14801:2016 .
The Below tests were performed for our previous submission devices and leveraged for the subject device: -
Gamma Sterilization Validation Test on LW Fixture according to ISO 11137-1, ISO 11137-2, . and ISO 11137-3 referenced in K223924 (LW Implant System)
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. End User Sterilization Validation Test Report on LW Retraction Cap according to ISO 17665-1, and ISO 17665-2 referenced in K231079 (LW Retraction Cap)
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. Shelf-Life Test on LW Fixture according to ASTM F1980 referenced in K223924 (LW Implant Svstem)
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Biocompatibility testing on LW Fixture according to ISO 10993-1:2018 referenced in K223924 . (LW Implant System)
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Biocompatibility testing on LW Retraction Cap according to ISO 10993-1:2018 referenced in ● K231079 (LW Retraction Cap)
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LAL endotoxin testing on LW Fixture according to USP 43, referenced in K223924 (LW Implant System)
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. Surface Modification Information on LW Fixture referenced in K223924 (LW Implant System)
A brief description of the leveraged information is as follows.
[Surface Modification Information]
The surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. The surface modification with SLA (sand-blasted, large-grit, acid-etched) was provided. To compare surface modification between the subject and predicate device, surface roughness, surface composition analysis, SEM imaging, and ICP analysis were provided, and it demonstrates substantial equivalence.
[Gamma Sterilization Validation]
For devices delivered in a sterile state, such as Implants, a sterility assurance level (SAL) of 10 has been validated in accordance with ISO 11137-1 "Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices". The validation took into account the worst-case scenario, and the results prove equivalence to the predicate device.
[End User Sterilization Validation]
The non-sterile abutments are intended to be sterilized by the end user. The recommended sterilization conditions have been validated through the end-user sterilization, following ISO 17665-1 "Sterilization of health care products - Moist heat - part 1: Requirements for the development. validation, and routine control of a sterilization process for medical devices", ISO 17665-2 "Sterlization of health care products – Moist heat – part 2: Guidance on the application of ISO 17665-1", and the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The validation considered the worst-case scenario, and the results demonstrated equivalence to the predicate device.
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Ossvis
[Biocompatibility Testing]
Biocompatibility Testing was performed in accordance with ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" 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', Guidance for Industry and Food and Drug Administration Staff". Cytotoxicity testing was performed according to ISO 10993-5.
[Shelf-life Testing]
The devices provided in a sterile state underwent Shelf-life testing in accordance with ASTM F1980, "Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices". The worstcase scenario was tested, and the results demonstrated that the devices are equivalent to the predicate devices. The shelf-life for the Implant is 5 years, and throughout this time frame, the devices will function as intended without any degradation. Please note that the devices will not be labeled as 'nonpyrogenic ' when they are marketed.
[Fatigue Testing]
To evaluate performance of the subject device, Dynamic Fatigue, and Static Compression Strength tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801:2016, "Dentistry – Implants – Dynamic fatigue test for endosseous dental implants" under the worst-case scenario. As a result, our dental implant system is expected to function properly for its intended use, which is to replace the patient's natural tooth and restore chewing function.
[Bacterial Endotoxin Testing]
To address the presence of bacterial endotoxins, the devices corresponding to implants should meet the pyrogen limit specifications as specified in the FDA guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" and USP "Medical Devices – Bacterial Endotoxin and Pyrogen Tests". Therefore, our dental implants were tested for bacterial endotoxin under USP "Bacterial
Endotoxins Test", and USP "Medical Devices – Bacterial Endotoxin and Pyrogen Tests". The test results have met the acceptance criteria and demonstrated the substantial equivalence with the predicate device.
[MR Safety]
Non-clinical worst-case MRI review was performed to evaluate the subject devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 4 9.2 (2 01 9): 7 8 3-795), based on the entire system including all implants and abutments and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
The non-clinical testing results demonstrate that the subject devices are substantially equivalent to the predicate devices.
Conclusion
The documentation submitted in this premarket notification demonstrates the LL Implant System is substantially equivalent to the primary predicate and reference devices.