LW UCLA Abutment

K231235 · Ossvis Co., Ltd. · NHA · Sep 15, 2023 · Dental

Device Facts

• Record ID: K231235
• Device Name: LW UCLA Abutment
• Applicant: Ossvis Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Sep 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The LW UCLA Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Device Story

The LW UCLA Abutment is a dental implant component used to support prosthetic restorations like crowns, bridges, or overdentures. It consists of a Co-Cr-Mo alloy main body and a POM plastic sleeve. The device is provided non-sterile and requires end-user sterilization before clinical use. It is designed to connect to the LW Fixture and LW Abutment Screw (LW Implant System). The abutment is used by dental professionals in a clinical setting to restore a patient's chewing function. It acts as an interface between the endosseous implant and the final prosthesis. The device is non-active and does not involve software or algorithms.

Clinical Evidence

No clinical data. Bench testing only. Sterilization validation performed per ISO 17665-1 and ISO 17665-2. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Main body: Co-Cr-Mo alloy (ASTM F1537). Plastic sleeve: POM (ASTM F1855). Connection types: Hex and Non-Hex. Dimensions: 4.5mm diameter, 10.0mm P/H. Sterilization: End-user (moist heat). Non-active, mechanical device.

Indications for Use

Indicated for patients requiring dental implant-supported prosthetic restorations, including crowns, bridges, or overdentures, to restore chewing function.

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

• Hiossen Prosthetic System (K140507)

Reference Devices

• LW Implant System (K223924)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 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.

9-15-23

Ossvis Co., Ltd. % April Lee Consultant Withus Group Inc. 106 Superior Irvine, California 92620

Re: K231235

Trade/Device Name: LW UCLA Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 16, 2023 Received: August 16, 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 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 531-542 of the Act); 21 CFR 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 ([e-mail]) or phone [phone] 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) K231235

Device Name LW UCLA Abutment

Indications for Use (Describe)

The LW UCLA 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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: [e-mail] Tel. [phone] Fax. [phone]

#### Device Information

- Trade Name: LW UCLA Abutment ●
- 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: 09/08/2023

#### Predicate Devices:

Primary Predicate

- K140507, Hiossen Prosthetic System by OSSTEM Implant Co., Ltd. ●
Reference device

- . K223924, LW Implant System by Ossvis Co., Ltd.
#### Indication for Use:

The LW UCLA Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

#### Device Description:

The LW UCLA Abutment is compatible with the LW Fixture and LW Abutment Screw in the LW Implant System, K223924.

| Name | Uses | Surface<br>Treatment | Fixture<br>Connection |
|------------------|-----------------------------------------------------------------------------------------------|----------------------|-----------------------|
| LW UCLA Abutment | The Abutment is used as a support of prosthesis<br>to restore the patient's chewing function. | N/A | Hex 2.48<br>/ Non-Hex |

LW UCLA Abutment is made of Co-Cr-Mo alloy (ASTM F1537) in the main body and POM (ASTM F1855) in the plastic sleeve, and it is provided non-sterile, which are required to be sterilized by the enduser before use.

#### The dimensions of subject device are as following:

| No | Device Name | Dimension |
|----|------------------|---------------------------------------------------------------------------------------------|
| 1 | LW UCLA Abutment | ${\text{\O}}$ 4.5 (D) x 10.0 mm (P/H, when the main body and plastic sleeve are connected.) |

# Official Correspondent

Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: [e-mail] Phone: [phone] Fax: [phone]

{4}------------------------------------------------

Design Envelope

| Wall Thickness | Minimum 0.4 mm |
|--------------------|----------------|
| Pose Height | Minimum 4.0 mm |
| Angular Correction | 0° |

#### Materials:

- The main body of LW UCLA Abutment is fabricated from Co-Cr-Mo Alloy(Cobalt-Chrome-. Molybdenum Alloy) of ASTM F1537
- The plastic sleeve of LW UCLA Abutment is fabricated from POM(Polyoxymethylene) of ASTM . F1855

### Summaries of Technological Characteristics & Substantial Equivalence Discussion

#### LW UCLA Abutment

| | Subject Device | Predicate Device |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K231235 | K140507 |
| Device Name | LW UCLA Abutment | Hiossen Prosthetic system |
| Abutment Name | LW UCLA Abutment | NP-Cast Abutment |
| Manufacturer | Ossvis Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Product Code | NHA | NHA |
| Regulation | 21 CFR 872.3630 | 21 CFR 872.3630 |
| Appearance | Image: LW UCLA Abutment | Image: Hiossen Prosthetic system |
| Indications for Use<br>Statement | The LW UCLA Abutment is intended for use with a<br>dental implant to provide support for prosthetic<br>restorations such as crowns, bridges, or<br>overdentures | The Hiossen Prosthetic system is intended for use<br>with a dental implant to provide support for<br>prosthetic restorations such as crowns, bridges, or<br>over-dentures |
| Connection Type | Hex, Non-Hex | Hex, Non-Hex |
| Diameter (Ø) | 4.5 | 4.0, 4.5 |
| G/H | 1.0, 3.0 | 1.0, 3.0 |
| P/H (mm) | 10.0 | 10.0 |
| Angulation | 0° | 0° |
| Material | Main Body: Co-Cr-Mo Alloy<br>Plastic Sleeve: POM | Body: Co-Cr-Mo Alloy<br>Plastic Sleeve: POM |
| Casting Material | Non-precious metal alloy | Non-precious metal alloy |
| Surface treatment | N/A | N/A |
| Sterilization | End User Sterilization | End User Sterilization |
| Substantial Equivalence Discussion | | |
| The LW UCLA Abutment has the same indication for use, material, design feature, surface treatment, and sterilization as the<br>predicate device (K140507). The difference between the two products is the abutment design However the design of both | | |

products is very similar, and this difference doesn't affect the performance. Device comparison shows the equivalence between the subject and predicate device.

{5}------------------------------------------------

#### Non-Clinical Test Data

The following non-clinical tests were conducted on the subject device, LW UCLA Abutment to prove the safety and performance:

- . 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 .

Biocompatibility Testing was performed according to ISO 10993-1:2009, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and to 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". The result demonstrated the biocompatibility of the material used.

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 UCLA Abutment is substantially equivalent to the primary predicate and reference devices.