(180 days)
No
The summary describes a mechanical dental abutment and its materials, compatibility, and non-clinical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is an abutment for a dental implant, which provides support for prosthetic restorations. It is a component of an implant system and does not directly treat a disease or condition.
No
The device is an abutment for dental implants, providing support for prosthetic restorations. It is a structural component, not used for diagnosing medical conditions.
No
The device description explicitly states the abutments are made of Ti-6AI-4V-ELI (ASTM F136), indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for prosthetic dental restorations. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant component made of titanium. It does not involve reagents, analyzers, or any components typically associated with in vitro diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The LW Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The LW Implant System - Abutment consists of the LW Solid, LW Angled, and LW Vis Abutment. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136), and they are provided non-sterile, which are required to be sterilized by the end-user before use.
The LW Implant System – Abutment is compatible with the LW Fixture and LW Abutment Screw in the LW Implant System, K223924.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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:
- Surface Modification Information: Evaluation performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. TiN (Titanium Nitride) coating information such as chemical composition analysis, coating thickness, SEM imaging, surface roughness, scratch test data was provided. The surface treatment applied to the subject devices demonstrates substantial equivalence to the predicate.
- End User sterilization Validation: Performed under ISO 17665-1 and ISO 17665-2, and included in a previously cleared submission identified as reference device (K223924).
- Biocompatibility Tests: Performed under 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.
- Fatigue test: 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.
- MRI Safety Information: 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.
Key results: The non-clinical testing results demonstrate that the subject devices are substantially equivalent to the predicate devices.
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 25, 2024
Ossvis Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K233167
Trade/Device Name: LW Implant System - Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 27, 2024 Received: February 28, 2024
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 (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.
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
3
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) K233167
Device Name LW Implant System - Abutment
Indications for Use (Describe)
The LW Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
Submitter
Ossvis Co., Ltd. Woo Jin Lee 7F and B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si. Gyeonggi-do. Republic of Korea Email: wjl316@ossvis.com Tel. +82-31-360-0082 Fax. +82-31-360-0058
Device Information
- Trade Name: LW Implant System Abutment ●
- Common Name: Endosseous dental implant abutment
- . Classification Name: Endosseous Dental Implant Abutment
- . Product Code: NHA
- Panel: Dental
- Regulation Number: 21 CFR 872.3630
- Device Class: Class II
- . Date Prepared: 03/20/2024
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- . K161689, OSSTEM Implant System – Abutment by OSSTEM Implant Co., Ltd.
Reference Device
- K182091, Osstem Abutment System by OSSTEM Implant Co., Ltd. ●
- K223924, LW Implant System by OSSVIS Co., Ltd. ●
Indications for Use:
The LW Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
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
5
Device Description:
The LW Implant System - Abutment consists of the LW Solid, LW Angled, and LW Vis Abutment. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136), and they are provided non-sterile, which are required to be sterilized by the end-user before use.
The LW Implant System – Abutment is compatible with the LW Fixture and LW Abutment Screw in the LW Implant System, K223924.
| Name | Uses | Surface Treatment | Fixture
Connection |
|--------------------|--------------------------------------------------------------------------------------------------|-----------------------------|--------------------------------------|
| LW Solid Abutment | | TiN-Coating (Partial, Full) | Hex 2.48
/ Non-Hex |
| LW Angled Abutment | The Abutment is used as a support of
prosthesis to restore the patient's
chewing function. | None | Hex 2.48
(Type A, B)
/ Non-Hex |
| LW Vis Abutment | | TiN-Coating (Partial, Full) | Hex 2.48
/ Non-Hex |
The dimensions of subject devices are as following:
| No | Device Name | Dimension |
|---|---|---|
| 1 | 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) | ||
| 2 | LW Angled Abutment | 15, 17, 25, 30° (Angle) |
| Ø 4.5, 5.0, 6.0 (D) | ||
| x 2.0, 4.0 mm (G/H) | ||
| X 8.0 mm (P/H) | ||
| 3 | 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) |
Materials:
- The subject abutments are fabricated from Ti-6A1-4V of ASTM F136 .
6
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) # | N/A | K161689 | K223924 |
| Device Name | LW Implant System – Abutment | OSSTEM Implant System - | |
| Abutment | LW Implant System | ||
| Abutment Name | LW Solid Abutment | Rigid Abutment | LW Solid Abutment |
| Manufacturer | Ossvis Co., Ltd. | OSSTEM Implant Co., Ltd. | Ossvis Co., Ltd. |
| Product Code | NHA | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: Subject Device Appearance | Image: Predicate Device Appearance | Image: Reference Device Appearance |
| 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, 5.0, 5.5, 6.0, 6.5, 7.0 |
| 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 |
| P/H (mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 |
| Material | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) |
| Surface treatment | TiN-coating | TiN-coating | Non-coating |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalence Discussion | |||
| The LW Solid Abutment is intended for the same use as the primary predicate. K161689. The material, surface treatment |
Summaries of Technological Characteristics & Substantial Equivalence Discussion
LW Solid Abutment
sterilization method, and dimensions are identical to the primary predicate device. The LW Solid Abutment with non-oating was cleared under K223924. This submission seeks to introduce a different surface treatment such as TiN-coated surface treatment. The device comparison chart demonstrates the substantial equivalence between the subject and predicate devices.
LW Angled Abutment
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| 510(k) # | N/A | K182091 | K223924 |
| Device Name | LW Implant System - Abutment | Osstem Abutment System | LW Implant System |
| Abutment Name | LW Angled Abutment | Angled Abutment | LW Angled Abutment |
| Manufacturer | Ossvis Co., Ltd. | OSSTEM Implant Co., Ltd. | Ossvis Co., Ltd. |
| Product Code | NHA | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: Subject Device Appearance | Image: Reference Device Appearance | Image: Reference Device Appearance |
| Connection Type | Hex, Non-Hex | Hex, Non-Hex | Hex, Non-Hex |
| Diameter (Ø) | 4.5, 5.0, 6.0 | 4.0, 4.5, 5.0, 6.0 | 4.5, 5.0, 6.0 |
| G/H (mm) | 2.0, 4.0 | 2.0, 4.0 | 2.0, 4.0 |
| P/H (mm) | 8.0 | 8.0 | 8.0 |
| Angle (°) | 15, 17, 25, 30° | 17° | 15, 17, 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 | TiN-coating | Non-coating |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalence Discussion | |||
| The indications, material, surface treatment, angles, sterilization method, and dimensions are identical to the reference device |
material, surface treatment, angles, sterilization method, and dimensions are identical to K182091. The non-coated LW Angled Abutment with Hex B type was previously granted clearance under K223924. This submission seeks to include TiN-coated abutments and the Hex A type Angled Abutment. Therefore, the subject device exhibits substantial equivalence to the reference devices.
7
LW Vis Abutment
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| 510(k) # | N/A | K182091 | K223924 |
| Device Name | LW Implant System - Abutment | Osstem Abutment System | LW Implant System |
| Abutment Name | LW Vis Abutment | Transfer Abutment | LW Vis Abutment |
| Manufacturer | Ossvis Co., Ltd. | OSSTEM Implant Co., Ltd. | Ossvis Co., Ltd. |
| Product Code | NHA | NHA | NHA |
| Regulation | 872.3630 | 872.3630 | 872.3630 |
| Appearance | Image: Subject Device Appearance | Image: Reference Device K182091 Appearance | Image: Reference Device K223924 Appearance |
| 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 | 4.5, 4.6, 5.0, 6.0, 7.0 |
| 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, 7.0 |
| P/H (mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 |
| Material | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI(ASTM F136) | Ti 6Al 4V ELI (ASTM F136) |
| Surface treatment | TiN-coating | TiN-coating | Non-coating |
| Sterilization | End User Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalence Discussion | |||
| The indications, material, surface treatment, sterilization method, and dimensions are identical to the reference device, K182091. | |||
| The LW Vis Abutment with non-coating was cleared under K223924. The aim of the submission is to add a different surface |
treatment such as TiN-coated surface treatment. The device comparison chart demonstrates the substantial equivalence between the subject and reference devices.
8
Non-Clinical Test Data
The following non-clinical tests were performed on the subject device or previously provided in a reference device, and the test results support that the subject device is substantially equivalent to the predicate devices.
. 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 TiN(Titanium Nitride) coating information such as chemical composition analysis, coating thickness, SEM imaging, surface roughness, scratch test data was provided. The surface treatment applied to the subject devices demonstrates substantial equivalence to the predicate.
- . End User sterilization Validation under ISO 17665-1 and ISO 17665-2 The end-user sterilization validation under ISO 17665-1 and ISO 17665-2 was included in a previously cleared submission identified as reference device (K223924).
. Biocompatibility Tests under ISO 10993-1 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.
. Fatigue test under ISO 14801
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.
● MRI Safety Information
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 devices are substantially equivalent to the predicate devices.
Conclusion
The documentation submitted in this premarket notification demonstrates the LW Implant System -Abutment is substantially equivalent to the primary predicate and reference devices.