(140 days)
No
The summary describes a mechanical dental abutment and its materials, with no mention of software, algorithms, or any AI/ML related terms. The performance studies focus on sterilization and biocompatibility, not algorithmic performance.
No.
The device description states its purpose is to provide support for prosthetic restorations and restore chewing function, which is a supportive rather than a therapeutic action.
No
The device, an LW UCLA Abutment, is described as intended for use with a dental implant to support prosthetic restorations and restore chewing function. Its purpose is to provide mechanical support, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is made of Co-Cr-Mo alloy and POM, indicating it is a physical hardware device, not software.
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 mouth, which is a surgical/dental procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a physical component (abutment) used in a dental implant system. It's made of materials suitable for implantation and supports a prosthesis.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the living body) to analyze samples and provide diagnostic information. This device is used in vivo (within the living body) as part of a dental restoration.
N/A
Intended Use / Indications 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.
Product codes
NHA
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
Treatment | Fixture
Connection |
|------------------|-----------------------------------------------------------------------------------------------|----------------------|-----------------------|
| LW UCLA Abutment | The Abutment is used as a support of prosthesis
to restore the patient's chewing function. | N/A | Hex 2.48
/ 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 | O 4.5 (D) x 10.0 mm (P/H, when the main body and plastic sleeve are connected.) |
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
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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 (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) 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)
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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 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
Treatment | Fixture
Connection |
|------------------|-----------------------------------------------------------------------------------------------|----------------------|-----------------------|
| LW UCLA Abutment | The Abutment is used as a support of prosthesis
to restore the patient's chewing function. | N/A | Hex 2.48
/ 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: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
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 | ||
| Statement | The LW UCLA Abutment is intended for use with a | |
| dental implant to provide support for prosthetic | ||
| restorations such as crowns, bridges, or | ||
| overdentures | The Hiossen Prosthetic system is intended for use | |
| with a dental implant to provide support for | ||
| prosthetic restorations such as crowns, bridges, or | ||
| 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 | |
| Plastic Sleeve: POM | Body: Co-Cr-Mo Alloy | |
| 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 | ||
| 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.