(221 days)
No
The summary describes a dental implant system made of standard materials and components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is used to support dental restorations, not to treat a disease or condition.
No
Explanation: The device is an implant system used for supporting dental restorations in edentulous areas, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical components made of materials like CP Ti Grade 4 and Ti-6AI-4V-ELI, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The LW Implant System is a dental implant system designed to be surgically placed in the jawbone to support dental restorations. It is a physical implant and associated components used in vivo (within the body), not for testing specimens in vitro (in a lab).
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes based on laboratory results.
Therefore, based on the provided information, the LW Implant System is a medical device, specifically a dental implant system, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LW Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The LW Implant System is dedicated for two stage surgical procedures and is intended for delayed loading. Also, implants with diameters larger than 5mm are indicated for molar regions.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The LW Implant System consists of a fixture, cover screw, healing abutments, and abutment screw.
The Fixture is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: internal hex connection, submerged type, tapered body, sided cutting edge. The Cover Screw and Healing Abutment are made of CP Ti Grade 4(ASTM F67) without any surface treatment.
The Abutments consist of the LW Solid, LW Angled, LW Vis and LW Temporary Abutment, and LW Abutment Screw. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136).
The LW Fixture, LW Cover Screw and LW Healing Abutment are provided sterile. The LW Solid Abutment, LW Angled Abutment, LW Vis Abutment, LW Temporary Abutment and LW Abutment Screw are provided non-sterile, which are required to be sterilized by the end-user before use.
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
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)
The following non-clinical tests were conducted on the subject devices to prove the safety and performance:
- Gamma Sterilization Validation Test under ISO 11137-1, ISO 11137-2, and ISO 11137-3
- End User sterilization Validation under ISO 17665-1 and ISO 17665-2
- Shelf-life Test under ASTM F1980
- Biocompatibility Tests - cytotoxicity according to ISO 10993-5
- Fatigue test under ISO 14801
- Bacterial Endotoxin Testing (LAL) under USP $$, and USP $$
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 (K181138), surface roughness, surface composition analysis, SEM imaging, and ICP analysis were provided, and it demonstrates substantial equivalence.
For devices delivered sterile such as Fixture, Healing Abutment, and Cover Screw, a sterility assurance level (SAL) of 10^-6 have been validated in accordance with ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirement, 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.
For devices delivered non-sterilized, the recommended sterilization condition has been validated through the end-user sterilization, according to ISO 17665-1 "Sterilization of health care products - Moist heat - part 1: Requirement, validation, and routine control of a sterilization process for medical devices", ISO 17665-2 "Sterilization of health care products -Moist heat - part 2: Guidance on the application of ISO 17665-1", and to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The worst-case scenario had been considered in the validation, and the results showed equivalence to the predicate device.
Shelf-life Testing was performed on the devices provided sterile in accordance with ASTM F1980 "Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices". The worst-case scenario was tested, and the results demonstrated that the devices are equivalent to the predicate devices. The shelf-life for the Fixture, Healing Abutment, and Cover Screw is 5 years, and the devices will function adequately as intended without any degradation during the shelf-life.
Biocompatibility Testing was performed according to ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and to 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. The result demonstrated the biocompatibility of the material used.
To evaluate the performance of subject devices, 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.
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 $$ "Medical Devices – Bacterial Endotoxin and Pyrogen Tests". Therefore, our dental implant fixtures were tested for bacterial endotoxin under USP $$ "Bacterial Endotoxins Test", and USP $$ "Medical Devices – Bacterial Endotoxin and Pyrogen Tests". The test result have met the acceptance criteria and demonstrated the substantial equivalence with the predicate device.
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 fixtures 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 device is substantially equivalent to 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.
K153639, K140091, K140934, K153350, K161689, K182091, K211090, K172100
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 two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ossvis Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K223924
Trade/Device Name: LW Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 5, 2023 Received: July 5, 2023
Dear April 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 (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 located 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
542 of the Act); 21 CFR 1000-1050.
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223924
Device Name LW Implant System
Indications for Use (Describe)
The LW Implant System is indicated for use in partially or fully edentulous mandbles and maxillae, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The LW Implant System is dedicated for two stage surgical procedures and is intended for delayed loading. Also, implants with diameters larger than 5mm are indicated for molar regions.
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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3
510(K) Summary
Submitter
Ossvis Co., Ltd. Young Jae Kim 7F and B1. 38. Burim-ro 170beon-gil. Dongan-gu. Anyang-si, Gyeonggi-do, Republic of Korea Email: yjk@ossvis.com Tel. +82-31-360-0082 Fax. +82-31-360-0058
Device Information
- Trade Name: LW 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: 08/08/2023
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- K181138, IS-III active System by Neobiotech Co., Ltd. ●
Reference Device
- K153639, OneQ-SL s-Clean Implant System by Dentis Co., Ltd.
- K140091, Xpeed AnyRidge Internal Implant System by MegaGen Implant Co., Ltd. ●
- K140934, HIOSSEN Implant System by HiOSSEN Inc.
- K153350, IBS Implant System by Innobiosurg Co., Ltd.
- K161689, OSSTEM Implant System – Abutment by OSSTEM Implant Co., Ltd.
- K182091, Osstem Abutment System by OSSTEM Implant Co., Ltd.
- K211090, ZENEX Implant System by Izenimplant Co., Ltd.
- K172100, URIS OMNI System by TruAbutment Inc. ●
Indication for Use:
The LW 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 terminal or intermediate abutment support for fixed bridgework. The LW Implant System is dedicated for two stage surgical procedures and is intended for delayed loading. Also, implants with diameters larger than 5mm are indicated for molar regions.
Official Correspondent
Withus Group Inc. April Lee 106 Superior. Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
4
Device Description:
The LW Implant System consists of a fixture, cover screw, healing abutments, and abutment screw.
The Fixture is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: internal hex connection, submerged type, tapered body, sided cutting edge. The Cover Screw and Healing Abutment are made of CP Ti Grade 4(ASTM F67) without any surface treatment.
The Abutments consist of the LW Solid, LW Angled, LW Vis and LW Temporary Abutment, and LW Abutment Screw. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136).
| Name | Uses | Surface Treatment | Fixture
Connection |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------------------------------------------|
| LW Cover Screw | The Cover Screw is used for protecting the inner
hole of a fixture during the healing period. | N/A | |
| LW Healing
Abutment | The Healing Abutment is used for protecting
inner hole of a fixture and adjusting the
appropriate gingival shape during the healing
period | N/A | Non-Hex |
| LW Solid Abutment
LW Angled
Abutment
LW Vis Abutment | The Abutment is used as a support of prosthesis
to restore the patient's chewing function. | N/A | Non-Hex
Hex 2.48
/ Non-Hex
Hex 2.48
/ Non-Hex |
| LW Temporary
Abutment | The Temporary Abutment is used temporarily
until making the final prosthesis to immediately
restore a patient's chewing function after
implantation as well as maintain an esthetic
appearance. Maximum duration of Temporary
Abutment is less than 6 months. | N/A | Hex 2.48
/ Non-Hex |
| LW Abutment Screw | The Abutment Screw is used for connect fixture
and abutment | N/A | Non-Hex |
The LW Fixture, LW Cover Screw and LW Healing Abutment are provided sterile. The LW Solid Abutment, LW Angled Abutment, LW Vis Abutment, LW Temporary Abutment and LW Abutment Screw are provided non-sterile, which are required to be sterilized by the end-user before use.
| No | Device Name | Dimension |
|---|---|---|
| 1 | LW Fixture | Ø 4.2 x 7.0, 8.5, 10.0, 11.5, 13.0, 15.0 mm (L) |
| Ø 4.55 x 10.0, 11.5, 13.0, 15.0 mm (L) | ||
| Ø 4.60 x 7.0, 8.5 mm (L) | ||
| Ø 5.00 x 10.0, 11.5, 13.0, 15.0 mm (L) | ||
| Ø 5.05 x 8.5 mm (L) | ||
| Ø 5.07 x 7.0 mm (L) | ||
| Ø 5.40 x 10.0, 11.5, 13.0, 15.0 mm (L) | ||
| Ø 5.45 x 7.0, 8.5 mm (L) | ||
| Ø 5.90 x 9.5, 11.0, 12.5 mm (L) | ||
| Ø 5.95 x 7.0, 8.0 mm (L) | ||
| Ø 6.55 x 9.5, 11.0, 12.5 mm (L) |
The dimensions of subject devices are as following:
5
| | | Ø 6.60 x 7.0, 8.0 mm (L)
Ø 6.80 x 9.5, 11.0, 12.5 mm (L)
Ø 6.85 x 7.0, 8.0 mm (L)
Ø 7.25 x 11.0, 12.5 mm (L)
Ø 7.30 x 9.5 mm (L)
Ø 7.35 x 7.0, 8.0 mm (L)
Ø 7.75 x 11.0, 12.5 mm (L)
Ø 7.80 x 9.5 mm (L)
Ø 7.85 x 7.0, 8.0 mm (L) |
|---|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | LW Cover Screw | Ø 3.6 (D) x 5.9 mm (H)
Ø 3.75 (D) x 6.9 mm (H)
Ø 3.9 (D) x 7.5 mm (H) |
| 3 | LW Healing Abutment | Ø 4.3, 4.8, 4.9, 5.3, 5.8, 6.3, 6.8, 7.3, 7.8, 8.3 (D)
x 2.9 / 3.9 / 4.9 / 5.9 / 6.9 / 7.9 / 8.9
3.0 / 4.0 / 5.0 / 6.0 / 7.0 / 8.0 / 9.0 mm (H) |
| 4 | LW Solid Abutment | Ø 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 (D)
x 1.0, 2.0, 3.0, 4.0, 5.0 (G/H)
x 4.0, 5.5, 7.0 mm (Post/H) |
| 5 | LW Angled Abutment | 15, 17, 25, 30° (Angle)
Ø 4.5, 5.0, 6.0 (D) x 2.0, 4.0 mm (G/H) |
| 6 | LW Vis Abutment | Ø 4.5, 4.6, 5.0, 6.0, 7.0 (D)
x 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 mm (G/H)
x 4.0, 5.5, 7.0 (Post/H) |
| 7 | LW Temporary
Abutment | Ø 4.5 (D)
x 1.0, 3.0 mm (G/H)
x 10 mm (Post/H) |
| 8 | LW Abutment Screw | Ø 2.3 (D) x 8.34 mm (L) |
Materials:
- The LW fixtures, Healing Abutment, and Cover Screw are fabricated from Pure titanium of ASTM . F67
- LW abutments are fabricated from Ti-6Al-4V of ASTM F136 ●
6
Summaries of Technological Characteristics & Substantial Equivalence Discussion
LW Fixture
| Subject Device | Primary Predicate | Reference Device | Reference Device | |
|---|---|---|---|---|
| 510(k) # | N/A | K181138 | K153639 | K140091 |
| Device Name | LW Implant System | IS-III active System | OneQ-SL s Clean Implant System | Xpeed AnyRidge Internal Implant |
| System | ||||
| Manufacturer | Ossvis Co., Ltd. | Neobiotech Co., Ltd. | Dentis Co., Ltd. | MegaGen Implant 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 | ||||
| Indications for | ||||
| Use Statement | The LW 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 | ||||
| terminal or intermediate abutment | ||||
| support for fixed bridgework. The | ||||
| LW Implant System is dedicated for | ||||
| two stage surgical procedures and is | ||||
| intended for delayed loading. Also, | ||||
| implants with diameters larger than | ||||
| 5mm are indicated for molar | ||||
| regions. | The IS-III active 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 terminal or | ||||
| intermediate abutment support for | ||||
| fixed bridgework. IS-III active | ||||
| System is dedicated for two stage | ||||
| surgical procedures and for | ||||
| immediate loading when there is | ||||
| good primary stability and an | ||||
| appropriate occlusal load. Also, | ||||
| implants with diameters larger | ||||
| than 5mm are indicated for molar | ||||
| regions. | The OneQ-SL s Clean 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 | ||||
| terminal or intermediate abutment | ||||
| support for fixed bridgework. This | ||||
| system is dedicated for one and | ||||
| two stage surgical procedures. | ||||
| This system is intended for | ||||
| delayed loading. | The product 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 of fully | ||||
| edentulous individuals. | ||||
| It is used to restore a patient's | ||||
| chewing function. Smaller | ||||
| implants (less than 6.0mm) 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 Connection | |||
| • Submerged Fixture | ||||
| • Tapered & Straight body shape | ||||
| • sided cutting edge with self | ||||
| tapping | • Internal Hex Connection | |||
| • Submerged Fixture | ||||
| • Tapered & Straight body shape | ||||
| • sided cutting edge with self- | ||||
| tapping | • Internal Hex Connection | |||
| • Submerged Fixture | ||||
| • Tapered & Straight body shape | ||||
| • sided cutting edge with self- | ||||
| tapping | • Internal Hex Connection | |||
| • Submerged Fixture | ||||
| • Tapered & Straight body shape | ||||
| Diameter (Ø) | 4.2, 4.55, 4.6, 5.0, 5.05, 5.07, 5.4, | |||
| 5.45, 5.9, 5.95, 6.55, 6.6, 6.8, 6.85, | ||||
| 7.25, 7.3 7.35, 7.75, 7.8, 7.85 | 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular: 3.7, 3.9, 4.2, 4.7, 5.2 | ||
| Wide: 6.0, 7.0, 8.0 | 4.0, 4.4, 4.9, 5.4, 5.9 | |||
| (For normal ridge) | ||||
| 6.4, 6.9, 7.4, 7.9, 8.4 | ||||
| (For low ridge) | ||||
| Length (mm) | 7.0, 8.0, 8.5, 9.5, 10.0, 11.0, | |||
| 11.5, 12.5, 13.0, 15.0 | 8.5, 10.0, 11.5, 13.0, 15.0 | |||
| (For a diameter of 3.5) | Regular: 7.0, 8.0, 10.0, 12.0, 14.0 | |||
| Wide: 7.0, 8.0, 10.0, 12.0 | 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 | |||
| (For normal ridge) | ||||
| (For diameters of 4.2 – 5.45) | ||||
| 7.0, 8.0, 8.5, 9.5, 10.0, 11.0, | ||||
| 11.5, 12.5 | ||||
| (For diameters of 5.9 – 7.85) | 7.3, 8.5, 10.0, 11.5, 13.0, 15.0 | |||
| (For a diameter of 4.0 – 5.5) | ||||
| 7.3, 8.5, 10.0, 11.5, 13.0 | ||||
| (For a diameter of 6.0 – 7.0) | 7.9, 9.4, 10.9, 12.4, 14.4 | |||
| (For low ridge) | ||||
| Material | Pure Titanium Grade 4 | |||
| (ASTM F67) | Pure Titanium Grade 4 | |||
| (ASTM F67) | 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 | SLA |
| Substantial Equivalence Discussion | ||||
| The LW Fixture has the same indication for use, material, design feature, structure, surface treatment, and sterilization as the primary predicate. The difference between |
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the subject and primary predicate, K181138 is dimensions. The predicate device does not include all dimensional combinations of the such as the fixture with diameter 4.2 x length 7.0 mm and fixtures with 1.0mm. However, the difference is covered by the reference is covered by the reference devices such as K 15639 and K 14091 which have a wider range of diament and issue in performance or safety. Therefore, it is substantialy equivalent.
LW Cover Screw
| Subject Device | Reference Predicate | Reference Device | |
|---|---|---|---|
| 510(k) # | N/A | K153639 | K140934 |
| Device Name | LW Implant System | OneQ-SL s-Clean Implant System | HIOSSEN Implant System |
| Manufacturer | Ossvis Co., Ltd. | Dentis Co., Ltd. | HIOSSEN Inc. |
| Product Code | NHA | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: Subject Device Appearance | Image: Reference Predicate Appearance | Image: Reference Device Appearance |
| Diameter (Ø) | 3.6, 3.75, 3.9 | 3.6 | 3.03, 3.58, 3.25, 3.4, 3.75, 3.9 |
| Height (mm) | 5.9, 6.9, 7.5 | 5.9 | 5.25, 5.9, 6.25, 6.85, 6.9, 7.5 |
| Material | Pure Titanium Grade 4 | ||
| (ASTM F67) | Pure Titanium Grade 4 | ||
| (ASTM F67) | Pure Titanium Grade 4 | ||
| (ASTM F67) | |||
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Surface treatment | N/A | N/A | Anodizing |
| Substantial Equivalence Discussion | |||
| The LW Cover Screw has the same indications for use, material, sterilization, and similar design as the primary predicate. The difference between | |||
| subject and primary predicate is dimension. The subject device has a wider range of diameters and lengths. The reference device, K140934 was added since it | |||
| encompasses the dimension range of the subject device and supports substantial equivalence. |
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LW Healing Abutment
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| 510(k) # | N/A | K140934 | K211090 |
| Device Name | LW Implant System | HIOSSEN Implant System | ZENEX Implant System |
| Manufacturer | Ossvis Co., Ltd. | HiOSSEN Inc. | Izenimplant Co., Ltd. |
| Product Code | NHA | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: LW Implant System Appearance | Image: HIOSSEN Implant System Appearance | Image: ZENEX Implant System Appearance |
| Diameter (Ø) | 4.3, 4.8, 4.9, 5.3, 5.8, 6.3, 6.8, 7.3, 7.8, 8.3 | 4.3, 4.8, 5.3, 6.3, 7.3 | 4.3 ~ 9.0 |
| Height (mm) | 2.9 – 9.0 | 3.0, 4.0, 5.0, 7.0 | 2.0 ~ 9.0 |
| Material | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) | Ti 6Al 4V ELI (ASTM F136) |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Surface treatment | N/A | N/A | N/A |
| Substantial Equivalence Discussion | |||
| The LW Healing Abutment has the same intended use, material, surface treatment, sterilization and similar design as the reference device (K140934). | |||
| The difference between subject and reference device, K140934 is the dimensions. The subject device has a wider range of diameters and heights. The wider range of | |||
| dimensions is intended to meet the needs of each patient and does not raise an issue in safety and performance of the device. The reference device (K211090). |
encompasses the diameter range of the subject device and supports substantial equivalence.
LW Solid Abutment
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| 510(k) # | N/A | K161689 | K172100 |
| Device Name | LW Implant System | OSSTEM Implant System - Abutment | URIS OMNI System |
| Abutment Name | LW Solid Abutment | Rigid Abutment | D Basis Abutment – Direct Type |
| Manufacturer | Ossvis Co., Ltd. | OSSTEM Implant Co., Ltd. | TruAbutment Korea Co., Ltd. |
| Product Code | NHA | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: LW Solid Abutment | Image: Rigid Abutment | Image: D Basis Abutment |
| Diameter (Ø) | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 | 4.0, 4.6, 5.0, 6.0, 7.0 | 4.0, 4.5, 5.5, 6.5 |
| G/H (mm) | 1.0, 2.0, 3.0, 4.0, 5.0 | 1.0, 2.0, 3.0, 4.0, 5.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 |
| P/H (mm) | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm | 4.0, 5.5, 7.0 mm |
9
| Material | Ti 6Al 4V ELI
(ASTM F136) | Ti 6Al 4V ELI
(ASTM F136) | Ti 6Al 4V ELI
(ASTM F136) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------|------------------------------|
| Surface treatment | Non-coating | TiN-coating | Non-coating |
| Substantial Equivalence Discussion | | | |
| The intended use, material, sterilization, dimension, and general design of the LW Solid Abutment are same as the reference devices, K161689. The difference between
the two devices is surface treatment. To support this discrepancy, K172100 was added. Therefore, it is substantially equivalent. | | | |
LW Angled Abutment
| LW Angled Abutment | Subject Device | Reference Device | Reference Device |
|---|---|---|---|
| 510(k) # | N/A | K182091 | K153350 |
| Device Name | LW Implant System | Osstem Abutment System | IBS Implant System |
| Abutment Name | LW Angled Abutment | Angled Abutment | Angled Abutment |
| Manufacturer | Ossvis Co., Ltd. | OSSTEM Implant Co., Ltd. | Innobiosurg Co., Ltd. |
| Product Code | NHA | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: LW Angled Abutment | Image: Osstem Abutment System | Image: IBS Implant System |
| Connection Type | Hex, Non-Hex | Hex, Non-Hex | Internal Hex |
| Diameter (Ø) | 4.5, 5.0, 6.0 | 4.0, 4.5, 5.0, 6.0 | 4.0, 4.5, 5.0 |
| G/H (mm) | 2.0, 4.0 | 2.0, 4.0 | 1.0, 2.0, 3.0, 4.0 |
| P/H (mm) | 8.0 | 8.0 | 1.0, 2.0, 3.0, 4.0 |
| Angle (°) | 15, 17, 25, 30° | 17° | 15, 25, 30° |
| Material | Ti 6Al 4V ELI | ||
| (ASTM F136) | Ti 6Al 4V ELI | ||
| (ASTM F136) | Ti 6Al 4V ELI | ||
| (ASTM F136) | |||
| Surface treatment | Non-coating | TiN-coating | Non-coating |
| Substantial Equivalence Discussion | |||
| The LW Angled Abutment has the same intended use, material, sterilization, and similar design as the reference devices, K182091. The difference between the two |
devices is angulation and surface treatment.
To support angulation and surface treatment, K153350 was added. Therefore, it is substantially equivalent.
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LW Vis Abutment
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| 510(k) Number | N/A | K182091 | K172100 |
| Device Name | LW Implant System | Osstem Abutment System | URIS OMNI System |
| Abutment Name | LW Vis Abutment | Transfer Abutment | D Basis Abutment – Cemented Type |
| Manufacturer | Ossvis Co., Ltd. | OSSTEM Implant Co., Ltd. | TruAbutment Korea Co., Ltd. |
| Product Code | NHA | NHA | NHA |
| Regulation Number | 872.3630 | 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: LW Vis Abutment | Image: Transfer Abutment | Image: D Basis Abutment |
| Connection Type | Hex, Non-Hex | Hex, Non-Hex | Hex, Non-Hex |
| Diameter (Ø) | 4.5, 4.6, 5.0, 6.0, 7.0 | 4.0, 4.6, 5.0, 6.0, 7.0 | 4.0, 4.5, 5.5, 6.5 |
| G/H (mm) | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 |
| P/H (mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 mm |
| Material | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI | |
| (ASTM F136) | Ti 6Al 4V ELI | ||
| (ASTM F136) | |||
| Surface treatment | Non-coating | TiN-coating | Non-coating |
| Substantial Equivalence Discussion | |||
| The intended use, material, sterilization, dimension, and general design of the LW Solid Abutment are same as the reference devices, K182091. The difference | |||
| between the two devices is surface treatment. To support this discrepancy, K172100 was added. Therefore, it is substantially equivalent. |
LW Temporary Abutment
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) # | N/A | K161689 |
| Device Name | LW Implant System | OSSTEM Implant System - Abutment |
| Abutment Name | LW Temporary Abutment | Temporary Abutment |
| Manufacturer | Ossvis Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Product Code | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: Subject Device Appearance | Image: Reference Device Appearance |
| Connection Type | Hex, Non-Hex | Hex, Non-Hex |
| Diameter (Ø) | 4.5 | 4.0, 4.5 |
| G/H (mm) | 1.0, 3.0 | 1.0, 3.0 |
| Post/H (mm) | 10 | 10 |
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| Material | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) |
|---|---|---|
| Maximum duration | Less than 6 months | Less than 6 months |
| Surface treatment | N/A | N/A |
| Substantial Equivalence Discussion | ||
| The LW Temporary Abutment has the same intended use, surface treatment, sterilization, fixture connection type and similar design as the reference device, | ||
| K161689. Although the post shape differs from the reference device, we do not consider the differences between devices a serious thing that affect the safety and | ||
| effectiveness of the device since the device is temporarily used in the human body unlike other permanent abutments. Therefore, it is substantially equivalent. |
LW Abutment Screw
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) # | N/A | K161689 |
| Device Name | LW Implant System | OSSTEM Implant System - Abutment |
| Abutment Name | LW Abutment Screw | Abutment Screw |
| Manufacturer | Ossvis Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Product Code | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: LW Abutment Screw | Image: Abutment Screw |
| Diameter (Ø) | 2.3 mm | 2.0, 2.05, 2.2, 2.3, 2.5 mm |
| Length (mm) | 8.34mm | 3.35, 5.6, 7.5, 8.35, 9.6, 10.2 mm |
| Material | Ti 6Al 4V ELI | |
| (ASTM F136) | Ti 6Al 4V ELI | |
| (ASTM F136) | ||
| Surface treatment | N/A | N/A |
| Substantial Equivalence Discussion | ||
| The LW Abutment Screw has the identical to the reference device, K161689 in intended use, design, material, and surface treatment. Device comparison shows the | ||
| equivalence between the subject and predicate device. |
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Non-Clinical Test Data
The following non-clinical tests were conducted on the subject devices to prove the safety and performance:
- Gamma Sterilization Validation Test under ISO 11137-1, ISO 11137-2, and ISO 11137-3
- End User sterilization Validation under ISO 17665-1 and ISO 17665-2
- . Shelf-life Test under ASTM F1980
- . Biocompatibility Tests - cytotoxicity according to ISO 10993-5
- . Fatigue test under ISO 14801
- Bacterial Endotoxin Testing (LAL) under USP , and USP
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 (K181138), surface roughness, surface composition analysis, SEM imaging, and ICP analysis were provided, and it demonstrates substantial equivalence.
For devices delivered sterile such as Fixture, Healing Abutment, and Cover Screw, a sterility assurance level (SAL) of 10° have been validated in accordance with ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirement, 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.
For devices delivered non-sterilized, the recommended sterilization condition has been validated through the end-user sterilization, according to ISO 17665-1 "Sterilization of health care products - Moist heat - part 1: Requirement, validation, and routine control of a sterilization process for medical devices", ISO 17665-2 "Sterilization of health care products -Moist heat - part 2: Guidance on the application of ISO 17665-1", and to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The worst-case scenario had been considered in the validation, and the results showed equivalence to the predicate device.
Shelf-life Testing was performed on the devices provided sterile in accordance with ASTM F1980 "Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices". The worst-case scenario was tested, and the results demonstrated that the devices are equivalent to the predicate devices. The shelf-life for the Fixture, Healing Abutment, and Cover Screw is 5 years, and the devices will function adequately as intended without any degradation during the shelf-life. Please note that the devices will not be labeled as 'non-pyrogenic' when they are marketed.
Biocompatibility Testing was performed according to ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and to 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. The result demonstrated the biocompatibility of the material used.
To evaluate the performance of subject devices, 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
13
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.
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 implant fixtures were tested for bacterial endotoxin under USP "Bacterial Endotoxins Test", and USP "Medical Devices – Bacterial Endotoxin and Pyrogen Tests". The test result have met the acceptance criteria and demonstrated the substantial equivalence with the predicate device.
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 fixtures 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 device is substantially equivalent to the predicate device.
Conclusion
The documentation submitted in this premarket notification demonstrates the LW Implant System is substantially equivalent to the primary predicate and reference devices.