(81 days)
Not Found
Not Found
No
The summary describes a light-cured composite restorative material for dental use, with no mention of AI or ML capabilities or related data/performance metrics.
No
The device is described as a composite restorative material used for dental fillings, which aims to restore function and form rather than treat a disease or condition.
No
The device, Renamel Pack, is described as a light-cured composite restorative material for dental use, specifically for placement of posterior restorations. This indicates it is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "system consisting of light cured composite restorative 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 use is for "placement of posterior restorations" and "posterior composite restoration." This describes a material used in the mouth for dental procedures, not for testing samples outside the body to diagnose conditions.
- Device Description: The device is described as "light cured composite restorative materials." This is a material used for filling cavities and restoring teeth, not for performing diagnostic tests.
- 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, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information about a patient's health status
Therefore, Renamel Pack is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Renamel Pack should be used for placement of posterior restorations. It can be used as the total restoration or in a layering technique to establish excellent proximal contact prior to overlay of a finishing material.
Use for:
- Posterior composite restoration.
- Contact development in posterior restoration prior to occlusal overlay of more polishable materials.
Product codes
EBF
Device Description
Renamel Pack Composite is a system consisting of light cured composite restorative 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a person with their arms outstretched, or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 18 2000
Mr. Michael O'Malley President Cosmedent®, Inc. 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611
Re : K993659 Trade Name: Renamel Pack Requlatory Class: II Product Code: EBF Dated: January 5, 1999 Received: January 5, 1999
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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
1
Page 2 - Mr. O'Malley
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 premarket notification" (21 CFR 807.97). 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.fdaf.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'K993659'. The characters are rendered in a bold, sans-serif font, giving them a distinct and easily readable appearance. The black color of the characters contrasts sharply against the white background, enhancing their visibility.
COSMEDENT®
INDICATIONS FOR USE STATEMENT
510(K) Number (if known):
Kagaresa
Device Name:
Renamel Pack
Indication for Use:
Renamel Pack should be used for placement of posterior restorations. It can be used as the total restoration or in a layering technique to establish excellent proximal contact prior to overlay of a finishing material.
Use for:
- Posterior composite restoration. 1.
- Contact development in posterior restoration prior to occlusal overlay of more 2. polishable materials.
DESCRIPTION OF DEVICE
Renamel Pack Composite is a system consisting of light cured composite restorative materials.
A confidential chemical analysis of Renamel Pack Composite may be found in Appendix B.
(PLEASE DO NOT WRITE BELOW THIS LINE)
| Susan Rue Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K993659 |
| Prescription Use | OR | Over-the Counter Use | ||
|---|---|---|---|---|
| (Per 21 CFR 801.109) |