(64 days)
The DuraFlex thermoplastic resin is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
The DuraFlex material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
This document is a 510(k) Premarket Notification for a dental resin called DuraFlex. The content describes the device, its intended use, and argues for its substantial equivalence to a predicate device, Lucitone FRS Flexible Dental Resin.
Here's an analysis of the provided information regarding acceptance criteria and studies:
Assessment:
Based on the provided document, the device described, DuraFlex, is a thermoplastic resin used in dentistry. The submission is a 510(k) Premarket Notification which, by its nature, demonstrates substantial equivalence to a previously legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies.
Therefore, the requested information about acceptance criteria, device performance tables, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training set details are not applicable to this type of submission.
Explanation regarding 510(k) Substantial Equivalence:
A 510(k) submission does not typically involve clinical trials or performance studies to establish new safety and effectiveness. Instead, it aims to demonstrate that a new device is "substantially equivalent" to a predicate device that is already legally marketed in the U.S. This means the new device is as safe and effective as the predicate device, or it has different technological characteristics but does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as a legally marketed predicate device.
The "study" described in this document is primarily a comparison of technological characteristics between DuraFlex and Lucitone FRS Flexible Dental Resin.
Specific answers to your questions based on the provided text:
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A table of acceptance criteria and the reported device performance:
- Not applicable. This document does not present acceptance criteria for performance or a table of reported device performance in the way a clinical study would. The focus is on demonstrating substantial equivalence to a predicate device. The performance is implied to be equivalent to the predicate.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No test set data or clinical study data is presented in this document. The "study" is a comparison of material properties and intended use.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No ground truth establishment by experts is described as there is no test set or clinical study.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication method is described.
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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. This device is a dental resin, not an AI-powered diagnostic tool. MRMC studies are irrelevant in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a material science product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth in the context of clinical performance is established or used for this submission. The "ground truth" for substantial equivalence is the known characteristics and safety record of the predicate device.
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The sample size for the training set:
- Not applicable. This is a material, not a machine learning algorithm. There is no training set mentioned or implied.
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How the ground truth for the training set was established:
- Not applicable. There is no training set described.
In summary, the provided document is a regulatory submission focused on substantial equivalence for a physical dental material (resin), not a clinical study to establish new performance metrics for a diagnostic or AI-driven device.
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Image /page/0/Picture/1 description: The image shows the logo for Cosmetic Dental Materials, with the acronym "cdm" in bold, black letters. To the right of the acronym, the full name of the company is written in a smaller font. In the upper right corner of the image, the abbreviation "FEB" is visible.
8 2007
CDM Inc. 812 Water Ave NE Albany OR 97321 Phone: 541-928-4444 Fax: 541-928-2444
510 (K) Summary
Submitter Name:
Submitter Address:
Submitter Telephone: Submitter Facsimile:
Contact Person:
CDM Inc.
812 Water St NE Albany OR 97321
541-928-4444 541-928-2444
Bob Bowers Chief Operating Officer
Date Summary Prepared:
October 23, 2006
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CDM Inc. DuraFlex Original Premarket 510(K) Notification
SECTION 9: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR.807.92.
9.1 SUBMITTER INFORMATION
| a. Company Name: | CDM Inc. |
|---|---|
| b. Company Address: | 812 Water St NEAlbany OR 97321 |
| c. Company Telephone:Company Facsimile: | 541-928-4444541-928-2444 |
| d. Contact Person: | Bob BowersChief Operating Officer |
| e. Date Summary Prepared: | October 23, 2006 |
| 9.2 DEVICE IDENTIFICATION | |
| a. Trade/Proprietary Name: | DuraFlex |
| b. Classification Name: | Denture relining, repairing or re |
Denture relining, repairing or rebasing resin. 21 CFR 872.3760
9.3 IDENTIFICATION OF PREDICATE DEVICES
The DuraFlex material is a thermoplastic resin used to fabricate partial or full removable dentures, as well as occlusal splints and night guards. This material is substantially equivalent to Lucitone FRS Flexible Dental Resin manufactured by Dentsply International. This material is commercially available in the United States.
9.4 DEVICE DESCRIPTION
The DuraFlex material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
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CDM Inc. DuraFlex Original Premarket 510(K) Notification
9.5 SUBSTANTIAL EQUIVALENCE
The DuraFlex thermoplastic resin is substantial equivalent to Lucitone FRS Flexible Dental Resin. The fundamental characteristics are similar: the DuraFlex thermoplastic resin is similar in design, function, physical properties and intended use to the predicate device.
9.6 INDICATIONS FOR USE
The DuraFlex material is a thermoplastic resin intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
9.7 TECHNOLOGICAL CHARACTERISTICS
Both the DuraFlex and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Bowers Chief Operating Officer CDM, Incorporated 812 Water Avenue, NE Albany, Oregon 97321
FEB $ 2007
Re: K063626
Trade/Device Name: DuraFlex™ Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: January 29, 2007 Received: February 05, 2007
Dear Mr. Bowers:
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 coan. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device an be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FFD may public further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Robert Bowers
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sura Ruano
Chiu S. Lin. PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number | K063626 |
|---|---|
| Device Name | DuraFlex |
Page 1 of 1
Indications for use:
The DuraFlex thermoplastic resin is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. Dental Device Class II, 872.3760
Do not write below this line - Continue on another page if needed
Prescription Use
(Per 21 CFR 801.109)
OR
Over the counter
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K63676
§ 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.