(150 days)
No
The device description and performance studies focus on the physical properties, sterilization, and biocompatibility of a dental implant component. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device's intended use is to provide support for prosthetic restorations and protect abutments, which are mechanical functions, not therapeutic.
No
The device is described as a component used for supporting prosthetic restorations and protecting abutments in the oral cavity, with no mention of diagnosing conditions or diseases.
No
The device is a physical component made of POM (Polyoxymethylene) with specific dimensions, intended for use with dental implants. It requires sterilization and undergoes biocompatibility and performance testing related to its physical properties.
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 restorations in the oral cavity, which is a direct clinical application within the body.
- Device Description: The device is a component of a dental implant system, used to protect abutments in the oral cavity. It's a physical component used in a surgical/restorative procedure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze samples like blood, urine, tissue, etc., to diagnose or monitor medical conditions. This device is used in vivo (within the body) as part of a dental restoration.
N/A
Intended Use / Indications for Use
The LW Retaction Cap 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 Retraction Cap is a component of the LW Implant System (K223924), and it is used with the LW Solid Abutment and LW Vis Abutment of the LW Implant System.
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)
The following non-clinical tests were conducted to prove the safety and performance of the LW Retraction Cap.
End User Sterilization Validation: The recommended sterilization conditions have been validated by performing the end-user sterilization validation according to 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" and ISO 17665-2 "Sterilization of health care products – Moist heat – part 2: Guidance on the application of ISO 17665-1 ". The worst-case scenario was considered in the test, and the results showed equivalency to the predicate device.
Biocompatibility Tests: Cytotoxicity Testing was performed according to ISO 10993-5 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".
Performance Tests: Tests for appearance and dimensions were performed to evaluate the performance of the LW Retraction Cap. The test results satisfied the acceptance criteria and support that the device will fit its compatible abutment and function properly as its intended use, which is to cover and protect an abutment.
The non-clinical testing results have met the acceptance criteria and demonstrated the substantial equivalence with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 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 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 text "U.S. Food & Drug Administration" in blue letters.
9-14-23
Ossvis Co., Ltd. % April Lee Consultant Withus Group Inc. 106 Superior Irvine, California 92620
Re: K231079
Trade/Device Name: LW Retraction Cap Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 11, 2023 Received: August 11, 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
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 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 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.
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231079
Device Name
LW Retraction Cap
Indications for Use (Describe)
The LW Retaction Cap 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)
Prescription Use (Part 21 CFR 801 Subpart D)
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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 Retraction Cap
- Common Name: Endosseous Dental Implant Abutment
- Classification Name: Abutment, Implant, Dental, Endosseous
- Product Code: NHA
- Panel: Dental
- Regulation Number: 21 CFR 872.3630
- Device Class: Class II
- . Date Prepared: 09/12/2023
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
- K161689, OSSTEM Implant System Abutment by OSSTEM Implant Co., Ltd. .
Indication for Use:
The LW Retraction Cap is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Device Description:
The LW Retraction Cap is a component of the LW Implant System (K223924), and it is used with the LW Solid Abutment and LW Vis Abutment of the LW Implant System.
| Name | Uses | Surface Treatment |
|---|---|---|
| LW Retraction Cap | Used to protect the LW Solid Abutment and LW Vis | |
| Abutment in the oral cavity | N/A |
The LW Retraction Cap is made of POM(Polyoxymethylene(ASTM F1855)) and provided nonsterile, which is required to be sterilized by the end-user before use.
The dimensions of subject device are as following:
| No | Device Name | Dimension |
|---|---|---|
| 1 | LW Retraction Cap | Ø 5.0, 6.0, 6.1, 6.7, 7.2, 7.7, 8.2, 8.7 mm |
| (D) x 5.5, 7.0, 8.5 mm (L) |
Materials:
- LW Retraction Cap is fabricated from POM(Polyoxymethylene) of ASTM F1855 .
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
Summaries of Technological Characteristics & Substantial Equivalence Discussion
LW Retraction Cap
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) # | K231079 | K161689 |
| Device Name | LW Retraction Cap | OSSTEM Implant System - Abutment |
| Abutment Name | LW Retraction Cap | Rigid Retraction Cap |
| Manufacturer | Ossvis Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Product Code | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: LW Retraction Cap | Image: OSSTEM Implant System - Abutment |
| Indications for | ||
| Use Statement | The LW Retraction Cap is intended for use with a | |
| dental implant to provide support for prosthetic | ||
| restorations such as crowns, bridges, or | ||
| overdentures. | The OSSTEM Implant System - Abutment is intended | |
| for use with a dental implant to provide support for | ||
| prosthetic restorations such as crowns, bridges, or | ||
| overdentures. | ||
| Uses | Used to protect the LW Solid Abutment and LW Vis | |
| Abutment in the oral cavity | Used for the protection of the Rigid Abutment on the | |
| oral cavity | ||
| Diameter (mm) | 5.0, 6.0, 6.1, 6.7, 7.2, 7.7, 8.2, 8.7 | 4.8, 6.0, 6.6, 7.7, 8.7 |
| Length (mm) | 5.5, 7.0, 8.5 | 5.5, 7.0, 8.5 |
| Material | POM (Polyoxymethylene) | |
| (ASTM F1855) | POM (Polyoxymethylene) | |
| (ASTM F1855) | ||
| Sterilization | N/A | N/A |
| Surface treatment | N/A | N/A |
| Maximum | ||
| duration for | ||
| clinical use | 30 days | Unknown |
| Substantial Equivalence Discussion |
The LW Retraction Cap has the same indication for use, material, design feature, surface treatment, and sterilization as the primary predicate.
The difference between the subject and primary predicate is difference does not raise any serious issues in performance or safety because it is used temporarily in the oral cavity and the size fits its compatible abutment considering the intended use of the device. Therefore, the subject device is substantial equivalence to the predicate device.
5
Non-Clinical Test Data
The following non-clinical tests were conducted to prove the safety and performance of the LW Retraction Cap.
. End User Sterilization Validation
The subject device is delivered non-sterile and is intended to be sterilized by the end user. The recommended sterilization conditions have been validated by performing the end-user sterilization validation according to 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" and ISO 17665-2 "Sterilization of health care products – Moist heat – part 2: Guidance on the application of ISO 17665-1 ". The worst-case scenario was considered in the test, and the results showed equivalency to the predicate device.
. Biocompatibility Tests
Cytotoxicity Testing was performed according to ISO 10993-5 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".
Performance Tests .
Tests for appearance and dimensions were performed to evaluate the performance of the LW Retraction Cap. The test results satisfied the acceptance criteria and support that the device will fit its compatible abutment and function properly as its intended use, which is to cover and protect an abutment.
The non-clinical testing results have met the acceptance criteria and demonstrated the substantial equivalence with the predicate device.
Conclusion
The documentation submitted in this premarket notification demonstrates the LW Retraction Cap is substantially equivalent to the primary predicate device.