(77 days)
NOT FOUND
No
The summary describes a physical dental composite material and its application, with no mention of software, algorithms, or any AI/ML related terms or concepts.
No
This device is a dental composite material used to facilitate the application of restorative materials and is classified as a Tooth Shade Resin Material, which are not typically considered therapeutic devices in the context of treating disease or ailment.
No
The device is described as a "low viscosity microfilled composite" used to facilitate the application of dental composite restorative materials, not to diagnose a condition.
No
The device description clearly states it is a "Brushable Dental Composite" supplied in "plastic syringes" and applied to an instrument. This indicates a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used to facilitate the application of dental composite restorative materials directly to teeth. This is a direct application to the patient's body for restorative purposes.
- Device Description: The device is a "Brushable Dental Composite" and a "Tooth Shade Resin Material." These are materials used in dental procedures performed directly on the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with bodily specimens.
Therefore, this device falls under the category of a dental restorative material used in direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Cosmedent BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, splinting, appiration of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.
Product codes
EBF
Device Description
TRADE NAME: BRUSHABLE COMPOSITE
COMMON NAME: Brushable Dental Composite
CLASSIFICATION NAME: Tooth Shade Resin Material (21 CFR 872.3690, Product code EBF)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior teeth
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 510(k) submission for BRUSHABLE COMPOSITE
Page 13 of 14
REVISED
510(k) SUMMARY
NOV 2 0 2009
As required by the Safe Medical Devices Act of 1990
DESCRIPTION OF THE APPLICANT DEVICE
TRADE NAME: BRUSHABLE COMPOSITE COMMON NAME: Brushable Dental Composite CLASSIFICATION NAME: Tooth Shade Resin Material (21 CFR 872.3690, Product code EBF)
Indications for Use: Cosmedent BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, splinting, appiration of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.
The technological characteristics of the applicant device are essentially identical to the predicate device.
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE
TRADE NAME: Bisco SCULPTING RESIN COMMON NAME: Brushable Dental Composite CLASSIFICATION NAME: Tooth Shade Resin Material (21 CFR 872.3690, Product code EBF) 510(k) Number: K030585
| EQUIVALENTS | Cosmedent
BRUSHABLE
COMPOSITE | Bisco Sculpting Resin |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Similarities | | |
| Intended Use | Both products are intended to be used to manipulate and
sculpt esthetic dental restorative materials | |
| Composition | Both products have substantially the same chemical
composition. They are light-cure, silica filled,
difunctional acrylic composites | |
| Physical/mechanical Aspects | Both products are low viscosity microfilled composites
and have similar physical and mechanical properties | |
| How supplied and used | Both products are supplied as preloaded, plastic
syringes. The material is extruded onto a suitable pad or
well and applied to the instrument | |
| Differences | | |
| Filler percentage | 36% | 30% |
SUBSTANTIAL EQUIVALENCE SUMMARY
Submitted by: James L. Sandrik, PhD Cosmedent, Inc. 401 N. Michigan Ave. Suite 2500 Chicago, IL 60611
1
Image /page/1/Picture/0 description: The image shows a logo with a bird-like figure with three lines extending from its head, resembling wings or feathers. The logo is encircled by text, which appears to be part of the organization's name or a related phrase. The text is arranged in a circular fashion around the bird figure, and the overall design has a formal and official appearance.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
. . . . . . .
NOV 2 0 2009
James L. Sandrik, Ph. D Director of Regulatory Affairs Cosmedent, Incorporated 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611
Re: K092730
Trade/Device Name: Brushable Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 3, 2009 Received: November 4, 2009
Dear Dr. Sandrik:
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). 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 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 may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Dr. Sandrik
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Cosmedent, Inc., 401 N. Michigan Ave., Suite 2500 _60611 510(k) submission for BRUSHABLE COMPOSITE Page 4 of 14
REVISED
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: MULTIPLE (BRUSHABLE COMPOSITE)
Indication For Use:
BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, achinting, and repair of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.
× 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 Device Evaluation (ODE)
Kein Muluy for Mise
(Division Sign-Off)
· Mision of Anesthesiology, General Hospital infection Control. Dental Devices
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