(81 days)
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Not Found
No
The summary describes a dental composite material and does not mention any AI or ML capabilities.
No
The device is described as a light-cured composite restorative material used for dental restorations. This aligns with materials used to repair a damaged tooth structure rather than to treat a disease or medical condition.
No
The device description states it is a "light cured composite restorative material," used for "restorations" and to "build up the lingual wall." This indicates it is a therapeutic or restorative material, 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 dental restorations (Class II, Class V, and Class IV). This is a direct treatment/restoration of a physical structure within the body.
- Device Description: It's a light-cured composite restorative material. This is a material used to repair or replace tissue.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens for diagnostic purposes.
Therefore, Renamel Sculptable Composite is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Renamel Scuptable Composite is used in Class II , Class V Restorations and to build up the lingual wall on Class IV anterior restorations.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Renamel Sculpt 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare. The symbol is composed of three curved lines that converge at the bottom.
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
K993658 Re : Renamel Sculpt Trade Name: 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
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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 regulations.
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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence reads 'K993658'. The characters and numbers are written in a bold, black font, which makes them stand out against the white background. The handwriting style appears somewhat informal.
INDICATIONS FOR USE STATEMENT
510(K) Number (if known):
Device Name:
Renamel Sculpt
Indication for Use:
Renamel Scuptable Composite is used in Class II , Class V Restorations and to build up the lingual wall on Class IV anterior restorations.
DESCRIPTION OF DEVICE
Renamel Sculpt 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Purdy
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K993658 |
| Prescription Use | OR | Over-the Counter Use | ||
|---|---|---|---|---|
| (Per 21 CFR 801.109) |