(64 days)
Lucitone FRS Flexible Dental Resin
Not Found
No
The summary describes a material used for fabrication and does not mention any computational or analytical capabilities.
No
The device is a material (thermoplastic resin) used for fabricating dental prostheses, not a device that directly treats a medical condition or disease. It is a component used in the manufacturing of therapeutic devices (dentures, splints, night guards).
No
The device is a material (thermoplastic resin) used for fabricating dental prostheses, such as dentures, splints, and night guards. It is not used to diagnose a medical condition or disease.
No
The device is a thermoplastic resin material used for fabricating dental prostheses, which is a physical material, not software.
Based on the provided information, the DuraFlex thermoplastic resin is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of dental prostheses (dentures, splints, night guards). These are devices used in the mouth of a patient, not for testing samples outside the body to diagnose or monitor a medical condition.
- Device Description: The description focuses on the material itself and how it's used to create physical dental devices. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic, prognostic, or monitoring information about a patient's health
The DuraFlex resin is a material used to create a medical device (a dental prosthesis), but it is not an IVD itself.
N/A
Intended Use / 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. 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
Product codes
EBI
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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Lucitone FRS Flexible Dental Resin
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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 NE |
| Albany OR 97321 | |
| c. Company Telephone: | |
| Company Facsimile: | 541-928-4444 |
| 541-928-2444 | |
| d. Contact Person: | Bob Bowers |
| Chief 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.
2
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.
3
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.
4
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
5
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