(234 days)
K0530160
K0530160
No
The 510(k) summary describes a material used for fabricating dental prosthetics and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
CFS FLEXIBLE™ is a material used in the fabrication of dental prosthetic appliances, not a therapeutic device itself. These appliances are used to restore function and comfort, but the material itself does not directly provide therapy.
No
The device is a material used for fabrication and repair of dental prosthetic appliances. It does not perform any diagnostic function.
No
The device description clearly states it is an "injection moldable, flexible, thermoplastic nylon," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the fabrication and repair of base plates for removable dental prosthetic appliances. This is a manufacturing process for a medical device that is placed in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a material (thermoplastic nylon) used to create dental prosthetics. It is not a reagent, instrument, or system intended for in vitro examination of specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting analytes, or providing diagnostic information.
Therefore, CFS FLEXIBLE™ is a medical device, specifically a material used in the manufacturing of dental prosthetics, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CFS FLEXIBLE™ is a break resistant material used in the fabrication and repair of base plates for removable dental prosthetic appliances where superior flexibility and patient comfort for the lifetime of the prosthetic are significant concerns. This includes, but not limited to, full and partial dentures, orthodontic devices, occlusal splints, and night guards.
Product codes
EBI
Device Description
CFS FLEXIBLE™ is an injection moldable, flexible, thermoplastic nylon with trace amouni: of colorant added.
CFS FLEXIBLE™ is used for fabricating removable dental prosthetic appliances such as in and partial dentures, orthodontics devices, occlusal splints and night guards both permanes and temporary. Because it can be used to create completely non-metallic prosthetics, 1 : perfect for making removable dental prosthetic @pliances for metal-allergic patients.
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)
K0530160
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
K0815537
JAN 22 2009
510(k) Summary As Required by 21 section 807.92 ( c )
| 1-Submitter Name: | Angel L. Fernandez dba Comfort and Flexible Systems |
|---|---|
| 2-Address: | 8223 Santa Fe Spring Road |
| Whittier, CA 90606 | |
| 3-Phone: | 562 693 3858 |
| 4-Fax: | 562 745 5607 |
| 5-Contact Person: | Mr Angel L Fernandez (President) |
| 6-Date summary prepared: | May 16th, 2008 |
| 7- Official Correspondent: | Mansour Consulting LLC |
| 8- Address: | 845 Aronson Lake Court. Roswell, GA 30075 USA |
| 9- Phone: | 678-908-8180 |
| 10- Fax: | 678-623-3765 |
| 11- Contact Person: | Jay Mansour, President |
12-Device Trade or Proprietary Name: CFS FLEXIBLE™
13-Device Common or usual name: Denture Relining, Repairing, or Rebasing resin
14-Device Classification Name: Denture Relining, Repairing, or Rebasing resin
15-Substantial Equivalency is claimed against TCS® Unbreakable, cleared under K0530160
16-Description of the Device:
CFS FLEXIBLE™ is an injection moldable, flexible, thermoplastic nylon with trace amouni: of colorant added.
CFS FLEXIBLE™ is used for fabricating removable dental prosthetic appliances such as in and partial dentures, orthodontics devices, occlusal splints and night guards both permanes and temporary. Because it can be used to create completely non-metallic prosthetics, 1 : perfect for making removable dental prosthetic @pliances for metal-allergic patients.
17 Intended use of the device: (refer to FDA form attached)
CFS FLEXIBLE™ is a break resistant material used in the fabrication and repair of base plati for removable dental prosthetic appliances where superior flexibility and patient comfort for t lifetime of the prosthetic are significant concerns. This includes, but not limited to, full as partial dentures, orthodontic devices, occlusal splints, and night guards.
18-Safety and Effectiveness of the device:
CFS FLEXIBLE™ is safe: and effective as the predicate device cited above.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, black and white design. The text is also in black and white and is written in all capital letters.
Public Health Service
JAN 2 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Angel L Fernandez dba Comfort and Flexible Systems C/O Mr Jay Mansour President Mansour Consulting, L L C 845 Aronson Lake Court Roswell, Georgia 30075
Re K081537
Trade/Device Name CFS FLEXIBLETM Regulation Number 21 CFR 872 3760 Regulation Name Denture Relining, Repairing, or Rebasing Resin Regulatory Class II Product Code EBI Dated December 8, 2008 Received January 21, 2009
Dear Mr Mansour
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantually 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
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 affectung 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
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2
Page 2 - Mr Mansour
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the DIVISIOn of Surveillance Systems at 240-276-3464 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
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Sincerely vours.
Anthony V. Ansteen for
Ginette Y Michaud, M D Acting 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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3
Indications for Use
510(k) Number (if known)
50815337
Device Name CFS FLEXIBLE™
Indications For Use
CFS FLEXIBLE™ is a break resistant material used in the fabrication and repar of base a CFS FLEXIBLE™ a a break resident material need in the rainment of the mortent combrition of the mort of the more
plates for removed by and services where superor flexibility plates for removable dential prosthent concerns This includes, but not limited to, full
for the lifetime of the prosthent are significant concerns This includes, but not l for the lifetime of the prosthetic are Significant Cornisher
and partial dentures, orthodontic devices, occlusal splints, and night guards
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Lievice Evaluation (ODE)
Susan Rino
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number K081537
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