(74 days)
Not Found
Not Found
No
The summary describes a dental composite material, which is a physical substance, not a software or system that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a restorative dental material used for various dental procedures, not for treating or preventing diseases or conditions.
No
The device, Renamel Flowable Composite, is described as a restorative dental material used for various dental repairs and restorations. Its intended use is to treat existing dental issues, not to identify or diagnose them.
No
The device description clearly states it is a "system consisting of light-cured flowable composite restorative dental materials," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (restorations, sealing margins, repairing defects, bonding, veneers) are all procedures performed directly on the patient's teeth.
- Device Description: The device is described as a "light-cured flowable composite restorative dental material." This is a material used in dental procedures, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, Renamel Flowable Composite is a dental restorative material used in direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Renamel Flowable Composite is used for Class V restorations, small occlusal restorations, to seal margins, to repair pitted areas in restorations, as a pit and fissure sealant, to repair marginal defects, for bonding of fibrous splints and for direct resin veneers.
Product codes
EBD
Device Description
Renamel Flowable Composite is a system consisting of light-cured flowable composite restorative dental materials.
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
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1998
Mr. Michael O'Malley President Cosmedent, Incorporated 5419 North Sheridan Road Chicago, Illinois 60640
Re : K974494 Renamel Flowable Composite Trade Name: Regulatory Class: II Product Code: EBD Dated: November 26, 1997 November 28, 1997 Received:
Dear Mr. O'Malley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸਿ substantially equivalent determination assumes compliance with ---the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. O'Malley
through 542 of the Act for devices under the Electronic enroduct Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your siste puivalence 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaracion cheroises, "REBECHMan", "Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timot Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
Cosmedent, Inc.
INDICATIONS FOR USE STATEMENT
510(K) Number (if known): K974494
Device Name: Renamel Flowable Composite
Indications for Use:
Renamel Flowable Composite is used for Class V restorations, small occlusal restorations, to seal margins, to repair pitted areas in restorations, as a pit and fissure sealant, to repair marginal defects, for bonding of fibrous splints and for direct resin veneers.
DESCRIPTION OF DEVICE
Renamel Flowable Composite is a system consisting of light-cured flowable composite restorative dental materials.
A confidential chemical analysis of Renamel Flowable Composite may be found in Appendix C.
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| Susan Pum Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K974494 |
| Prescription Use (Per 21 CFR 801.109) | Yes |
| OR | |
| Over-the-Counter Use No |