LW Retraction Cap
Device Facts
| Record ID | K231079 |
|---|---|
| Device Name | LW Retraction Cap |
| Applicant | Ossvis Co., Ltd. |
| Product Code | NHA · Dental |
| Decision Date | Sep 14, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
Indications 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 Story
LW Retraction Cap is a dental component used to protect LW Solid and LW Vis abutments within the oral cavity. It is a temporary device used for up to 30 days. The device is provided non-sterile and must be sterilized by the clinician before use. It functions as a protective cover for the abutment during the healing or restorative process. The healthcare provider selects the appropriate size based on the compatible abutment and places it over the abutment in the clinic. By protecting the abutment, it facilitates the prosthetic restoration process, ultimately benefiting the patient by maintaining the integrity of the implant site during the transition to final restoration.
Clinical Evidence
No clinical data. Bench testing only. Testing included end-user sterilization validation per ISO 17665-1/2, biocompatibility (cytotoxicity) per ISO 10993-5, and performance testing for appearance and dimensions to ensure proper fit with compatible abutments.
Technological Characteristics
Material: POM (Polyoxymethylene) per ASTM F1855. Form factor: Cap/cover for dental abutments. Dimensions: Diameters 5.0-8.7 mm, Lengths 5.5-8.5 mm. Connectivity: None. Sterilization: Non-sterile, validated for end-user moist heat sterilization.
Indications for Use
Indicated for use with dental implants to support prosthetic restorations including crowns, bridges, or overdentures in patients requiring dental implant abutment protection.
Regulatory Classification
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.
Special Controls
*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.)
Predicate Devices
- OSSTEM Implant System Abutment (K161689)
Submission Summary (Full Text)
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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.
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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
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# 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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## 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<br>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<br>(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
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## 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<br>Use Statement | The LW Retraction Cap is intended for use with a<br>dental implant to provide support for prosthetic<br>restorations such as crowns, bridges, or<br>overdentures. | The OSSTEM Implant System - Abutment is intended<br>for use with a dental implant to provide support for<br>prosthetic restorations such as crowns, bridges, or<br>overdentures. |
| Uses | Used to protect the LW Solid Abutment and LW Vis<br>Abutment in the oral cavity | Used for the protection of the Rigid Abutment on the<br>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)<br>(ASTM F1855) | POM (Polyoxymethylene)<br>(ASTM F1855) |
| Sterilization | N/A | N/A |
| Surface treatment | N/A | N/A |
| Maximum<br>duration for<br>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.
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## 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.
