(812 days)
Fabrication of temporary crowns, bridges, inlays and veneers. Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.
This product is ISO10477 Type 2 & Class 2, a light cured resin that forms the shape of a resin to make a temporary crown to protect the tooth for crown treatment for a certain period until the prosthesis is made. It is packaged in an impermeable syringe which is polymerized by light-cured energy and composed of base and photocatalytic agent.
The provided document is a 510(k) Pre-Market Notification for a dental device called CURA-Temp. It focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the information requested in your prompt is not available in this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparison table between the subject device (CURA-Temp) and its predicate device (TempXN28, currently marketed as Protemp Plus). This table implicitly shows the acceptance criteria by listing the predicate device's performance thresholds, largely based on ISO 10477 standards.
| Item | Acceptance Criteria (based on Predicate/ISO 10477) | Reported Device Performance (CURA-Temp) |
|---|---|---|
| Depth of cure | $\geq$ 70% of top surface | 99 % |
| Flexural Strength | $\geq$ 50 MPa | Avg. 83.5 MPa |
| Water Sorption | $\leq$ 40 µg/mm³ | Avg. 19.4 µg/mm³ |
| Solubility | $\leq$ 7.5 µg/mm³ | Avg. 2.72 µg/mm³ |
| Color Stability | No more than a slight change | No a slight change in colour |
| Shade Consistency | No more than a slight difference | No a slight change in colour |
| Surface Finish | A glossy surface | A glossy surface |
| Biocompatibility | Compliance with EN ISO 10993-1 | Compliance with EN ISO 10993-1 |
Note: The "acceptance criteria" here are inferred from the predicate device's performance and the ISO 10477 standards that both devices are tested against. The CURA-Temp's performance clearly meets or exceeds these criteria.
2. Sample sized used for the test set and the data provenance
This information is not provided in the document. The document refers to "non-clinical performance tests" and "biocompatibility tests" but does not specify sample sizes for these tests or the data provenance. Since it's a 510(k) submission, the data is likely from laboratory bench tests conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document describes bench testing and biocompatibility testing, which typically do not involve human experts establishing ground truth in the way a clinical study or image interpretation study would.
4. Adjudication method for the test set
This information is not provided. As above, adjudication methods are typically relevant for human-involved evaluations (e.g., clinical trials, image interpretations), which are not detailed here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. The CURA-Temp is a dental resin for temporary crowns, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The CURA-Temp is a physical medical device (dental resin) and does not involve algorithms or AI performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical performance tests (e.g., flexural strength, water sorption), the "ground truth" is established by physical measurements and adherence to international standards (ISO 10477). For biocompatibility, the "ground truth" is established by laboratory tests following ISO 10993 standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of a clinical diagnostic study.
8. The sample size for the training set
This information is not applicable/provided. This device is a physical product and does not involve AI or machine learning algorithms that require a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, there is no "training set" for this type of device.
{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 the FDA logo, which 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.
December 21, 2022
Mgnewton LTD. % Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt, Suite 200 Irvine, California 92620
Re: K202965
Trade/Device Name: CURA-Temp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: December 2, 2022 Received: December 5, 2022
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 (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.
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
{1}------------------------------------------------
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 mediation-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,
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. 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) K202965
Device Name CURA-Temp
Indications for Use (Describe)
Fabrication of temporary crowns, bridges, inlays and veneers. Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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 (K202965)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92
Date: Oct 6, 2021
1. 510K Applicant / Submitter:
MGNEWTON LTD. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si, Gyeongsangbuk-do, Republic of Korea Tel: +82-53-214-6287 Fax: +82-70-7469-2074
2. Submission Contact Person
LK Consulting Group USA, Inc. 1150 ROOSEVELT, SUITE 200 Irvine , CA 92620 Priscilla Chung Phone: 714 2025789 Ext Email: Juhee.C'@Lkconsultinggroup.com
3. Subject Device
- -. Trade Name : CURA-Temp
- -. Classification Name : Crown and Bridge, Temporary, Resin
- -. Regulation Number : 21 CFR 872.3770
- -. Regulation Name : Temporary crown and bridge resin
- -. Regulatory Class : II
- -. Product Code : EBG
4. Primary Predicate Device
- -. Trade Name : TempXN28 (currently marketed as Protemp Plus)
- -. 510(k) Number : K073296
- -. Regulation Number : 21 CFR 872.3770
- -. Regulation Name : Temporary crown and bridge resin
- -. Regulatory Class : II
- -. Product Code : EBG
5. Description:
This product is ISO10477 Type 2 & Class 2, a light cured resin that forms the shape of a resin to make a temporary crown to protect the tooth for crown treatment for a certain period until the prosthesis is made. It is packaged in an impermeable syringe which is polymerized by light-cured energy and composed of base and photocatalytic agent.
{4}------------------------------------------------
6. Indications for Use
Fabrication of temporary crowns, bridges, inlays, onlays and veneers. Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.
7. Substantial Equivalence Discussion:
The CURA-Temp is substantially equivalent to TempXN28 (K073296). The following comparison table is presented to demonstrate substantial equivalence.
| Item | Our Device | Equivalence Device | Degree | ||
|---|---|---|---|---|---|
| Manufacturer | MGNEWTON Ltd. | 3M ESPE AG | - | ||
| Product Name | CURA-Temp | TempXN28(currently marketed asProtemp Plus) | - | ||
| 510(k) Number | Pending | K073296 | - | ||
| Appearance | Image: CURA-Temp syringe | Image: 3M ESPE AG syringes | - | ||
| Design type | Syringe | Syringe | Identical | ||
| Depth of cure | 99 % | the bottom surface shallbe not less than 70% ofthat of the top surface | Different#1 | ||
| Flexural Strength | Avg. 83.5 MPa | $\geq$ 50 MPa | Different#2 | ||
| TechnicalEquivalence | WaterSorption | Avg. 19.4 µg/mm³ | $\leq$ 40 µg/mm³ | Different#3 | |
| Solubility | Avg. 2.72 µg/mm³ | $\leq$ 7.5 µg/mm³ | Different#4 | ||
| ColorStability | no a slight change in colour | shall show no more thana slight change in colour | Identical | ||
| Shadeconsistency | no a slight change in colour | shall show no more thana slight difference withthe colour indicated | Identical | ||
| Surface finish | A glossy surface | shall have a glossy surface | Identical | ||
| Accessory | -. CURA-Temp Polisher-. CURA-Temp Adhesive-. CURA-Temp Tray-. Bur | -. Polisher-. Adhesive-. Tray-. Bur | Identical | ||
| Condition ofuse | Used as a temporary crown for a teeththat needs restoring. | Used as a temporarycrown for a teeth thatneeds restoring. | Identical | ||
| Principles of operation | Raw materials are photopolymerized and applied to teeth needed to be repaired for temporary restoration. | Raw materials are photopolymerized and applied to teeth needed to be repaired for temporary restoration. | Identical | ||
| ClinicalEquivalence | Indications for Use | Fabrication of temporary crowns, bridges, inlays, onlays and veneers. Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal. | Fabrication of temporary crowns, bridges, inlays, onlays and veneers. Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal. | Identical | |
| Intended User | Dentist | Dentist | Identical | ||
| Application Area | Gum | Gum | Identical | ||
| Target Population | All age | All age | Identical | ||
| Period of use | A month | A month | Identical | ||
| BiologicalEquivalence | RawMaterial | No. | Materials | ||
| 1 | Bisphenol A glycidyl Methacrylate | ||||
| 2 | Urethane Dimethacrylate | ||||
| 3 | Triethyleneglycoldimethacrylate | ||||
| 4 | Glass | ||||
| 5 | Silane, dichlorodimethyl-, reaction products with silica | Bis-acrylic composite | Different #5 | ||
| 6 | Camphorquinone | ||||
| 7 | Ethyl 4-dimethylaminobenzoate | ||||
| 8 | Titanium(IV) oxide | ||||
| 9 | Yellow ferric oxide | ||||
| 10 | Iron(III) oxide, Red | ||||
| Bio-compatibility | Compliance with EN ISO 10993-1 | Compliance with EN ISO 10993-1 | Identical |
{5}------------------------------------------------
※ Gap Analysis
- #1 Difference (Depth of cure)
In terms of depth of cure, our product is 99% and the predicate device is 70% or more. But, the depth of cure of our product and the predicate device was tested in accordance with ISO 10477 and the criteria that the bottom surface shall be not less than 70% of that of the top surface was applied equally. Therefore, despite the difference in the depth of cure between our product and the predicate device, since both products were manufactured in compliance with ISO 10477, there are no difference in terms of clinical performance and safety.
- #2 Difference (Flexural Strength)
{6}------------------------------------------------
In terms of flexural strength, our product is an average of 83.5 MPa and the predicate device is ≥ 50 MPa. But, the Flexural Strength of our product and the predicate device was tested in accordance with ISO 10477 and the criteria that ≥ 50 Mpa was applied equally. Therefore, despite the difference in the Flexural Strength between our product and the predicate device, since both products were manufactured in compliance with ISO 10477, there are no difference in terms of clinical performance and safety.
- #3 Difference (Water Sorption)
In terms of water sorption, our product is an average of 19.4 /8/mm3 and the predicate device is ≤ 40 /8/mm3. But, the Water Sorption of our product and the predicate device was tested in accordance with ISO 10477 and the criteria that ≤ 40 /8/mm3 was applied equally. Therefore, despite the difference in the Water Sorption between our product and the predicate device, since both products were manufactured in compliance with ISO 10477, there are no difference in terms of clinical performance and safety.
4) #4 Difference (Solubility)
In terms of solubility, our product is an average of 2.72 48/mm3 and the predicate device is ≤ 7.5 48/mm3. But, the Solubility of our product and the predicate device was tested in accordance with ISO 10477 and the criteria that ≤ 7.5 48/mm3 was applied equally. Therefore, despite the difference in the Solubility between our product and the predicate device, since both products were manufactured in compliance with ISO 10477, there are no difference in terms of clinical performance and safety.
5) #5 Difference (Raw Material)
In current clinical restorative treatment, many types of resin composites are available for the replacement of natural tooth tissues. The raw materials of our product and the similar product have a little difference in specific components and their composition. However, both products belong to the category of bis-acrylic composite. It would be impossible to find the details of raw materials of other company's product, as they are trade secrets but in general bis-acrylic composite includes both bisphenol a glycidyl methacrylate and urethane dimethacrylate of our product. The predicate device is a CE certified device and its safety has been proved. We conducted the biological safety test of our product to confirm its bio safety. We confirmed the technical and clinical equivalence. Despite the difference in biological equivalence, the bis-acrylic composite, which is dental resin, is biologically safe.
These composites are considered to be same. For this reason, although there is difference of raw materials between our product and similar product, it does not affect the clinical safety of our product.
8. Performance Tests (Non-clinical)
Non-clinical performance tests were performed according to the test standard (ISO 10477;2004). The following tests for performance of the subject device have been conducted.
| Test Standard | Test Item |
|---|---|
| - | Appearance |
| - | Weight |
| - | Packaging |
{7}------------------------------------------------
| ISO 10477 | Flexural Strength |
|---|---|
| ISO 10477 | Water Sorption |
| ISO 10477 | Solubility |
| ISO 10477 | Shade consistency (Color) |
| ISO 10477 | Colour Stability |
| ISO 10477 | Sensitivity to Ambient Light |
| ISO 10477 | Dept of cure |
| ISO 10477 | Surface Finish |
The test results met all the requirements of ISO 10477 and based on that, we conclude that the subject device will perform as well as the predicate devices in the market.
9. Biocompatibility Test
The following tests for biocompatibility have been conducted on the subject device;
| Test Standard | Test Item |
|---|---|
| ISO 10993-5 | Cytotoxicity (Agar Diffusion) |
| ISO 10993-10 | Oral mucosa irritation |
| ISO 10993-10 | Skin Sensitization (LLNA) |
| ISO 10993-11 | Acute Systemic Toxicity (Oral) |
10. Conclusions:
Based on the information above, CURA-Temp has the same indications for use and the technological characteristics as the predicate device. Both the subject device and the predicate have shown similar performance results in these bench tests.
In conclusion, CURA-Temp is substantially equivalent to the predicate device as described herein.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.