(85 days)
The product is a thermoplastic dental resin intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
The product is a thermoplastic dental resin intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. The material is an acetal thermoplastic resin. The pellet version of the resin are melted and reshaped to form the dental device. The disc version of the material is milled to form the dental device.
This document is a 510(k) premarket notification for a dental device, "Duracetal," a thermoplastic dental resin. It focuses on demonstrating substantial equivalence to a predicate device, "Duraflex," rather than presenting a study proving that an AI/ML powered device meets acceptance criteria.
Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) cannot be extracted from this document.
The document details the device's technical specifications, indications for use, and a comparison with the predicate device, along with the performance standards it conforms to for demonstrating equivalence in a traditional medical device context.
Here's a summary of what is available in the document regarding performance and comparison, rephrased to align with the spirit of your request as much as possible for a non-AI/ML device:
Device: Duracetal (thermoplastic dental resin)
Predicate Device: Duraflex (thermoplastic dental resin)
1. A table of (performance) criteria and the reported device performance:
The document provides a comparison table (Table A on page 5) outlining the characteristics of Duracetal against its predicate, Duraflex. These are not "acceptance criteria" in the sense of a numerical performance threshold, but rather a demonstration of equivalence across key attributes.
| Criteria | Duracetal results | Predicate results (Duraflex) | Comparison |
|---|---|---|---|
| Indications for use | To be used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. | To be used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. | The indications for use are the same |
| Raw material | Thermoplastic dental resin | Thermoplastic dental resin | Both are the same |
| Sterility | Non-sterile | Non-sterile | Both are the same |
| Anatomical site | mouth | mouth | Both are the same |
| Single use | Not intended for single use | Not intended for single use | Both are the same |
| Re-processing | Not intended for re-processing | Not intended for re-processing | Both are the same |
| Rx use | yes | yes | Devices made from both resins are per a doctor's prescription / intervention. |
Additional Performance Data (not in a direct comparison table with specific results, but stated as conformance):
"The Duracetal thermoplastic resin was tested for conformance and / or developed in accordance with the following standards:" (page 6)
- ISO 10993-1: Biological evaluation of medical devices
- Specific biocompatibility tests conducted: Cytotoxicity, Sensitization, Irritation - intracutaneous reactivity, Subchronic toxicity
- ISO 20795-1: Dentistry - base polymers- part 1: Denture base polymers
- ASTM D792 Density
- ASTM D638 Tensile Strength
- ASTM D638 Tensile Modulus
- ASTM D790 Flexural strength
- ASTM D790 Flexural / Bending Modulus
- ASTM D570 Water sorption
- ASTM D256 Izod Impact, Notched
- ISO 13485: Medical devices- Quality management systems-requirements for regulatory purposes.
Reported Device Performance (Stated Conclusion):
"Results from the performance data (discussed above) demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device." (page 7)
2. Sample sized used for the test set and the data provenance: Not applicable. This is not an AI/ML development or validation study. The performance data is based on material testing to established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material testing to standards does not use human experts in this way for ground truthing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this type of device, "ground truth" is derived from adherence to established material performance standards (e.g., ASTM, ISO standards for dental materials and biocompatibility).
8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
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The Myerson Company Limited Cindy Buchoon-Legendre QA/RA Coordinator 3 Trinity Avenue Laventille, TRINIDAD & TOBAGO
November 2, 2017
Re: K172407
Trade/Device Name: Duracetal Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: August 18, 2017 Received: August 23, 2017
Dear Cindy Buchoon-Legendre:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional Application for a 510(k)
INDICATIONS FOR USE STATEMENT 4.0
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| See PRA Statement below. |
Indications for Use
| 510(k) Number (if known) | K172407 |
|---|---|
| Device Name | Duracetal |
| Indications for Use (Describe) | The product is a thermoplastic dental resin intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. |
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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Traditional Application for a 510(k) Name of new product: Duracetal
RTA response for 510(k) number K172407
Page 1 of 5
Image /page/3/Picture/4 description: The image shows the logo for Myerson. The word "myerson" is written in white letters on a gray background. Below the word is a red horizontal bar.
The Myerson Company Limited 3 Trinity Avenue Laventille, Trinidad and Tobago Telephone 1 868 623 1007 Fax 1 868 627 4594 Email info@myersontooth.com www.myersontooth.com
510(k) summary
SUBMITTER
Name: The Myerson Company Limited
Address: 3 Trinity Avenue, Laventille, Trinidad and Tobago
Phone: 1 868 623 1007
Fax number: 1 868 627 4594
Name of contact person: Cindy Buchoon-Legendre
Date the corrected summary was prepared: Aug 24 2017
DEVICE
Trade name - Duracetal
Common name - thermoplastic dental resin
Classification name - resin, denture, relining, repairing, rebasing (21 CFR 872.3760, Product Code EBI)
510K # of new product: K172407
PREDICATE DEVICE
Legally marketed device to which the Myerson Company Limited is claiming equivalence:
Company Name: The Myerson Company Limited
Trade name – Duraflex
Common name - thermoplastic dental resin
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Traditional Application for a 510(k) Name of new product: Duracetal
RTA response for 510(k) number K172407
Classification name - resin, denture, relining, repairing, rebasing (21 CFR 872.3760, Product Code EBI)
510K# of predicate: K063626
DEVICE DESCRIPTION
Description of the device: The product is a thermoplastic dental resin intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
Explanation of how the device functions: the resin is processed at a dental lab to make an oral device as determined by a dental practitioner.
Scientific concepts that form the basis for the device: The material is used to make dental devices which work to temporarily replace or support part of the anatomy of the oral cavity.
Significant physical and performance characteristics of the device: The material is an acetal thermoplastic resin. The pellet version of the resin are melted and reshaped to form the dental device. The disc version of the material is milled to form the dental device.
INDICATIONS FOR USE
Intended use of the device: The product is a thermoplastic dental resin intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night quards.
Description of the disease or conditions that the device will treat, prevent or mitigate: The material is used to make dental devices which work to temporarily replace or support part of the anatomy of the oral cavity.
COMPARISION WITH THE PREDICATE DEVICE
The Duracetal thermoplastic resin is substantially equivalent to the predicate, Duraflex thermoplastic resin. See table A. The devices share the same intended use and there are no new questions of safety and effectiveness.
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Traditional Application for a 510(k) Name of new product: Duracetal
RTA response for 510(k) number K172407
Page 3 of 5
| Criteria | Duracetalresults | Predicateresults(Duraflex) | Comparison |
|---|---|---|---|
| indications foruse | To be used forthe fabricationof partial or fullremovabledentures, aswell as occlusalsplints andnight guards. | To be used forthe fabricationof partial or fullremovabledentures, aswell as occlusalsplints andnight guards. | The indications for useare the same |
| Raw material | Thermoplasticdental resin | Thermoplasticdental resin | Both are the same |
| Sterility | Non-sterile | Non-sterile | Both are the same |
| Anatomical site | mouth | mouth | Both are the same |
| Single use | Not intendedfor single use | Not intendedfor single use | Both are the same |
| Re-processing | Not intendedfor re-processing | Not intendedfor re-processing | Both are the same |
| Rx use | yes | yes | Devices made fromboth resins are per adoctor's prescription /intervention. |
Table A
Summary of the technological characteristics of Duracetal compared to the predicate device, Duraflex.
Both products are purchased by dental labs and are then used to make oral devices as per the direction of a doctor / dental practitioner.
The technology for the pellet form is the same. Both the Duracetal pellets and the Duraflex pellets are intended to be melted and injection-molded within a laboratory environment to form dental devices. However, the heating temperature and time is different. This is to accommodate an even flow of the molten Duracetal material.
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Traditional Application for a 510(k) Name of new product: Duracetal
RTA response for 510(k) number K172407
Although both are from the same family of chemicals, the individual chemical composition is different. Biocompatibility results show that this difference does not affect safety and effectiveness.
The technology for the Duracetal disc is different. The disc is intended to be milled in a dental CNC machine to make the same devices.
The final devices, made from the Duracetal pellets, Duracetal discs or the predicate Duraflex pellets then go through the same steps. They are temporarily fitted on the patient by a doctor / dental practitioner.
PERFORMANCE DATA
The Duracetal thermoplastic resin was tested for conformance and / or developed in accordance with the following standards:
ISO 10993-1: Biological evaluation of medical devices
ISO 20795-1: Dentistry - base polymers- part 1: Denture base polymers
ASTM D792 Density
ASTM D638 Tensile Strength
ASTM D638 Tensile Modulus
ASTM D790 Flexural strength
ASTM D790 Flexural / Bending Modulus
ASTM D570 Water sorption
ASTM D256 Izod Impact, Notched
It is also conforming to ISO 13485: Medical devices- Quality management systemsrequirements for regulatory purposes.
The specific biocompatibility tests conducted were:
- Cytotoxicity
- Sensitization
- Irritation -intracutaneous reactivity ●
- Subchronic toxicity
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Traditional Application for a 510(k) Name of new product: Duracetal
RTA response for 510(k) number K172407
Page 5 of 5
Results from the performance data (discussed above) demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.
CONCLUSION
Based on the comparison of the Duracetal thermoplastic resin to the predicate Duraflex thermoplastic resin and based on the non-clinical testing, it is concluded that the Duracetal thermoplastic resin is substantially equivalent to the predicate device.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.