(90 days)
No
The 510(k) summary describes a mechanical dental abutment and its materials, dimensions, and compatibility with existing implant systems. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
No.
The device is a dental abutment designed to support prosthetic restorations (crowns, bridges, overdentures) on a dental implant, not to directly treat or cure a disease or condition. Its purpose is structural support for a prosthesis rather than therapeutic action.
No
The device is an abutment for dental implants, used to support prosthetic restorations. It does not perform any diagnostic function.
No
The device description clearly states it is a physical dental abutment made of materials like CCM and POM, and includes details about its dimensions and compatibility with implant systems. There is no mention of software as a component of the device itself.
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 mechanical function related to dental implants.
- Device Description: The description focuses on the materials, dimensions, and connection types of a physical component used in dental surgery and restoration.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition.
- Performance Studies: The performance studies mentioned are related to sterilization, biocompatibility, and MRI compatibility, which are relevant to implantable or surgically used devices, not IVDs.
IVD devices are specifically designed to perform tests on biological samples to aid in diagnosis, monitoring, or screening. This device's function is purely structural and mechanical within the context of dental restoration.
N/A
Intended Use / Indications for Use
Meta G 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 Meta G UCLA Abutment is used for prosthetic restoration. The Meta G UCLA Abutment consists of Meta G UCLA Abutment and abutment screws. The Meta G UCLA Abutment is made of CCM (ASTM F1537) and POM (ASTM F1855). The casting material to make prosthesis is also CCM. When cast a prosthesis with the Meta G UCLA Abutment, the post height above the transmucosal collar of the Meta G UCLA Abutment has to be taller than 4mm and maximum 7mm. The Meta G UCLA Abutment has Hex, Non Hex connection. Hex-type abutment should be used for single unit restorations and is not recommended for multiple tooth restorations. Non Hex-type abutment is for multiunit restorations only. No angulation is to be incorporated into the cast final device and abutments should not be used on implants placed at an angle. It is provided non-sterile, this should be user steam sterilized before use. The Meta G UCLA abutment is compatible with our own implant system: INNO SLA Submerged Implant System(K132242) by Cowellmedi Co., Ltd. and INNO SLA Submerged Narrow Implant System (K231395) by Cowellmedi Co., Ltd.
The design envelope for the Meta G UCLA Abutment is as follows:
Minimum Diameter: 4.5 mm (0.18 in)
Minimum Thickness : 0.8mm
Maximum Total Cuff Height : 4mm
Minimum Total Cuff Height : 1mm
Maximum Cuff Height of Casting CCM part : 3mm
Minimum Cuff Height of Casting CCM part : 0mm
Post height: minimum of 4mm and maximum of 7mm
Minimum Diameter: 4.5 mm (0.18 in)
Minimum Thickness : 0.93mm
Maximum Total Cuff Height : 4mm
Minimum Total Cuff Height : 1mm
Maximum Cuff Height of Casting CCM part : 3mm
Minimum Cuff Height of Casting CCM part : 0mm
Post height: minimum of 4mm and maximum of 7mm
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 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.
- Sterilization validating testing has been performed in accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization.
- Biocompatibility testing for the subject device has been performed in accordance with ISO 10993-3, 5, 10, 11.
- Biocompatibility of the abutment screw (Ti-6A1-4V) was included in a previously cleared submission identified as reference device (K201323).
- MR Environment Condition: Non-clinical worst-case MRI review was performed to evaluate the metallic Meta G UCLA abutment in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., 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 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodied, dental abutments and, fixation screws) 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 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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
Cowellmedi Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave, Suite 160 Irvine. California 92612
Re: K232546
Trade/Device Name: Meta G UCLA Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 26, 2023 Received: August 24, 2023
Dear Priscilla Chung:
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
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)
Device Name
Meta G UCLA Abutment
Indications for Use (Describe)
Meta G 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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510(k) Summary
(K232546)
This summary of 510(k) substantial equivalence and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date:
1. Applicant / Submitter:
Cowellmedi Co., Ltd. 48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, 46986, Republic of Korea Tel. + 82-51-314-2028
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine CA 92612 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device:
| Proprietary Name: | Meta G UCLA Abutment |
|---|---|
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Classification: | Class II, 21 CFR 872.3630 |
| Classification Product Code: | NHA |
Predicate and Reference Devices: 4.
- Primary Predicate Device: UCLA CCM Abutment (K192263) by DIO Corporation
- · Reference Device: INNO SLA Submerged Implant System (K201323) by Cowellmedi Co., Ltd.
- · Reference Device: INNO SLA Submerged Implant System (K132242) by Cowellmedi Co., Ltd.
5
- · Reference Device: INNO SLA Submerged Narrow Implant System (K231395) by Cowellmedi Co., Ltd.
5. Device Description:
The Meta G UCLA Abutment is used for prosthetic restoration. The Meta G UCLA Abutment consists of Meta G UCLA Abutment and abutment screws. The Meta G UCLA Abutment is made of CCM (ASTM F1537) and POM (ASTM F1855). The casting material to make prosthesis is also CCM. When cast a prosthesis with the Meta G UCLA Abutment, the post height above the transmucosal collar of the Meta G UCLA Abutment has to be taller than 4mm and maximum 7mm.
The Meta G UCLA Abutment has Hex, Non Hex connection. Hex-type abutment should be used for single unit restorations and is not recommended for multiple tooth restorations. Non Hex-type abutment is for multiunit restorations only. No angulation is to be incorporated into the cast final device and abutments should not be used on implants placed at an angle.
It is provided non-sterile, this should be user steam sterilized before use. The Meta G UCLA abutment is compatible with our own implant system.
- · INNO SLA Submerged Implant System(K132242) by Cowellmedi Co., Ltd.
- INNO SLA Submerged Narrow Implant System (K231395) by Cowellmedi Co., Ltd.
The design envelope for the Meta G UCLA Abutment is as follows.
Minimum Diameter: 4.5 mm (0.18 in) Minimum Thickness : 0.8mm Maximum Total Cuff Height : 4mm Minimum Total Cuff Height : 1mm Maximum Cuff Height of Casting CCM part : 3mm Minimum Cuff Height of Casting CCM part : 0mm Post height: minimum of 4mm and maximum of 7mm
Minimum Diameter: 4.5 mm (0.18 in) Minimum Thickness : 0.93mm Maximum Total Cuff Height : 4mm Minimum Total Cuff Height : 1mm Maximum Cuff Height of Casting CCM part : 3mm Minimum Cuff Height of Casting CCM part : 0mm Post height: minimum of 4mm and maximum of 7mm
6. Indications for Use:
Meta G UCLA Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
6
7. Performance Data (Non-Clinical):
The following 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.
- . Sterilization validating testing has been performed in accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization.
- . Biocompatibility testing for the subject device has been performed in accordance with ISO 10993-3, 5, 10, 11.
- . Biocompatibility of the abutment screw (Ti-6A1-4V) was included in a previously cleared submission identified as reference device (K201323).
- . MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic Meta G UCLA abutment in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., 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 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodied, dental abutments and, fixation screws) 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.
8. Substantial Equivalence
8.1. Comparison Chart
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) No. | K232546 | K192263 |
| Applicant | Cowellmedi Co., Ltd. | DIO Corporation |
| Trade Name | Meta G UCLA Abutment | UCLA CCM Abutment |
| Classificatio | ||
| n Name | Endosseous Dental Implant Abutment | |
| (872.3630) | Endosseous Dental Implant Abutment | |
| (872.3630) | ||
| Product | ||
| Code | NHA | NHA |
| Class | II | II |
| Material | CCM & POM | CCM & POM |
| Indications | ||
| For Use/ | ||
| Intended Use | Meta G UCLA Abutment is intended for | |
| use with a dental implant to provide | UCLA CCM Abutment is intended for use | |
| with a dental implant to provide support for |
7
| Subject Device | Predicate Device | |
|---|---|---|
| support for prosthetic restorations such as | ||
| crowns, bridges, or overdentures. | prosthetic restorations such as crowns, | |
| bridges, or overdentures. | ||
| Design | ||
| Limits | Image: Subject Device | Image: Predicate Device |
| Diameters | ||
| (mm) | 4.5 | 4.0 / 4.5 |
| Cuff (mm) | 1, 2, 3 mm | 1, 3 mm |
| Angulation | 0° | 0° |
| Sterile | Non-sterile | Non-sterile |
8.2. Substantial Equivalence Discussion
Meta G UCLA Abutment is substantially equivalent in indications for use, material, dimension, sterilization and similar design, technological characteristics as primary predicate device (K192263). The only difference is in design, but it is very minor and does not raise new questions. We identified refence devices (K13242 & K231395) which is used with the subject device, and another device (K201323) to leverage biocompatibility testing.
Based on the information provided herein, we determine that the subject device is substantially equivalent to the predicate device.
9. Conclusion:
Based on the testing result and a comparison of technological characteristics, Cowellmedi Co., Ltd. concludes that the Meta G UCLA Abutment is substantially equivalent to the predicate device.