(46 days)
NANO COMPOSITE is designed for Class I-V dental restorations, direct veneering of anterior teeth, splinting, and repair of composite or ceramic restorations.
Cosmedent NANO COMPOSITE is a light-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials possess physical and mechanical properties that allow them to function in the oral cavity with esthetic qualities that mimic natural tooth appearance.
The provided text is a 510(k) summary for a dental composite material, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable.
Here's the relevant information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device, Tetric EvoCeram. This involves comparing key physical and mechanical properties.
| Property | Acceptance Criteria (Predicate: Tetric EvoCeram) | Reported Device Performance (Cosmedent NANO COMPOSITE) |
|---|---|---|
| Compressive strength | 313 MPa | 400 MPa |
| Flexural strength | 120 MPa | 125 MPa |
| Modulus of elasticity | 9500 MPa | 12000 MPa |
| Radiopaque | Yes | Yes |
2. Sample size used for the test set and the data provenance
Not applicable. This is a material comparison study, not an AI/ML diagnostic study with a "test set" in that context. The data would have been generated from laboratory testing of the material. The document does not specify the sample sizes (e.g., number of specimens tested for each property) or data provenance in terms of country of origin, or if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the context of AI/ML diagnostics for medical images is not relevant here. The "ground truth" for material properties is established through standardized laboratory testing methods.
4. Adjudication method for the test set
Not applicable. No expert adjudication is described for material property testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML diagnostic device.
7. The type of ground truth used
The "ground truth" for the device's performance is based on the results of physical and mechanical properties testing performed according to implied standard laboratory methods.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 510(k) submission for NANO COMPOSITE
Page 17 of 23
APR 16 2007
510(k) SUMMARY
As required by the Safe Medical Devices Act of 1990
.DESCRIPTION OF THE APPLICANT DEVICE
TRADE NAME: Multiple (NANO COMPOSITE)
.. .
COMMON NAME: Nano-hybrid Dental Composite CLASSIFICATION NAME: Tooth Shade Resin Material (21 CFR 872.3690, Product code EBF)
Cosmedent NANO COMPOSITE is a light-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials possess physical and mechanical properties that allow them to function in the oral cavity with esthetic qualities that mimic natural tooth appearance.
The technological characteristics of the applicant device are essentially identical to the predicate device.
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE
TRADE NAME: Tetric EvoCeram COMMON NAME: Nano-hybrid Dental Composite CLASSIFICATION NAME: Tooth Shade Resin Material (21 CFR 872.3690, Product code EBF) 510(k) Number: K042819
| EQUIVALENTS | CosmedentNANO COMPOSITE | Ivoclar VivadentTETRIC EVO CERAM |
|---|---|---|
| Similarities | ||
| Intended Use | Both products have identical intended uses as esthetic dentalrestorative materials | |
| Composition | Both products have substantially the same chemical composition.They are light-cure, silica filled, difunctional acrylic composites | |
| Physical properties | Both products have similar physical and mechanical properties asshown below | |
| How supplied and used | Both products are supplied as preloaded, plastic-screw fed syringes.The material is extruded onto a suitable pad and placed in theprepared cavity and light cured | |
| Mechanical and Physical Properties | CosmedentNANO COMPOSITE | Ivoclar VivadentTETRIC EVOCERAM |
| Compressive strength | 400 MPa | 313 MPa |
| Flexural strength | 125 MPa | 120 MPa |
| Modulus of elasticity | 12000 MPa | 9500 MPa |
| Radiopaque | Yes | Yes |
| Differences | ||
| Number of shades | 13 | 16 |
SUBSTANTIAL EQUIVALENCE SUMMARY
Submitted by: James L. Sandrik, PhD Cosmedent, Inc. 401 N. Michigan Ave. Suite 2500 Chicago, IL 60611
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right and appears to be in flight. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health and Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
James L. Sandrik, PhD Director of Regulatory Affairs Cosmedent, Incorporated 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611
APR 1 6 2007
Re: K070583
Trade/Device Name: Nano Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 28, 2007 Received: March 01, 2007
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 Amendrants, 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 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 - James L. Sandrik, PhD
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 vours.
Syria Y. Michael M.D.
Chiu 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
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Page 4 of 23
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: MULTIPLE (NANO COMPOSITE)
Indication For Use:
NANO COMPOSITE is designed for Class I-V dental restorations, direct veneering of anterior teeth, splinting, and repair of composite or ceramic restorations.
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)
Susan Soares
Production POSCH 3 Jon Connell,
(k) Number
§ 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.