(16 days)
Not Found
Not Found
No
The provided 510(k) summary describes a material used for lining dentures and other dental applications. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The intended use and device description (though not found) point towards a material-based device, not a software or imaging-based one.
No
The device is used to line dentures and surgical splints, and as an impression material, which are not therapeutic uses but rather aids in the construction or maintenance of dental devices.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic aid to locate pressure areas on denture."
No
The provided 510(k) summary describes a material used for lining dentures and other dental applications, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The listed intended uses are all related to dental procedures and the creation/modification of dental devices (dentures, obturators, splints). These are applications that involve direct interaction with the patient's oral cavity or the creation of devices for use within the oral cavity.
- Lack of IVD Characteristics: IVDs are devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided description does not mention any such use or the analysis of biological samples.
The device appears to be a dental material used for various applications within the field of dentistry.
N/A
Intended Use / Indications for Use
Lining of ill fitting dentures Functional impression material for full dentures Impression material for construction of obturators Lining of surgical and periodontal splints Diagnostic aid to locate pressure areas on denture.
Product codes
EBI
Device Description
Not Found
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)
Not Found
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Terry L. Joritz-Lyons Director - Regulatory Affairs and Quality Assurance GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
MAR 2 9 2007
Re: K070698
Trade/Device Name: Coe Comfort Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: March 08, 2007 Received: March 15, 2007
Dear Ms. Joritz-Lyons:
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). Your over, 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 can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA mey publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Terry L. Joritz-Lyons
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,
Syltie Y. Michaud, M.D.
Čhiu 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
2
Indications for Use
510(k) Number (if known): K070698
Device Name: Coe Comfort
Indications for Use:
Lining of ill fitting dentures Functional impression material for full dentures Impression material for construction of obturators Lining of surgical and periodontal splints Diagnostic aid to locate pressure areas on denture.
Prescription Use × (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suver Runser
n of Anesthesiology, General Hospital cion Control, Dental Devices
510(k) Number: K670698
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