(46 days)
Temporary CROWN AND BRIDGE Resin is indicated for use as a temporary restorative material for crown and bridge, inlay, and/or onlay restorations.
Cosmedent TEMPORARY CROWN AND BRIDGE RESIN is a self-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials have sufficient physical properties to function in the oral cavity for up to 90 days and have esthetic qualities that mimic natural tooth appearance.
The provided text describes a 510(k) submission for a medical device, a Temporary Crown and Bridge Resin. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for proving new performance against acceptance criteria through a clinical study of the type usually associated with AI/software devices. Therefore, many of the requested points related to AI/software performance studies are not applicable to this document.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" in this context are the physical and mechanical properties of the predicate device (Luxatemp) that the applicant device (Cosmedent TEMPORARY C&B Filling Material) aims to be substantially equivalent to. The reported performance is the measured properties of the Cosmedent device.
| Property | Acceptance Criteria (Predicate: LUXATEMP) | Reported Device Performance (Cosmedent TEMPORARY C & B Filling Material) |
|---|---|---|
| Compressive strength | 220 MPa | 225 MPa |
| Flexural strength | 92 MPa | 82 MPa |
| Percent filler by weight | 44 | 46 |
| Radiopaque | Yes | Yes |
2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to material properties testing, not a clinical study with a "test set" in the context of AI/software or diagnostic performance. The testing would have been conducted in a laboratory setting. No information on the number of samples tested for the material properties is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties like compressive strength is established through standardized laboratory testing methods, not expert consensus.
4. Adjudication method for the test set: Not applicable. Material properties are measured objectively.
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/software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/software device.
7. The type of ground truth used: For the material properties (compressive strength, flexural strength, percent filler by weight, radiopacity), the ground truth is established through objective laboratory measurements following established standards for dental materials.
8. The sample size for the training set: Not applicable. This is not an AI/software device with a training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/software device.
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Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 510(k) submission for Temporary CROWN AND BRIDGE Resin Page 16 of 17
510(k) SUMMARY
As required by the Safe Medical Devices Act of 1990
DESCRIPTION OF THE APPLICANT DEVICE
MAY 16 7000
いついて、いつです。このままでのなくていているときになるときています。ことでもなくてきました
TRADE NAME: Multiple
COMMON NAME: Temporary Crown and Bridge Resin
CLASSIFICATION NAME: Temporary Crown and Bridge Resin (21 CFR 872.3770, Product code EBG)
Cosmedent TEMPORARY CROWN AND BRIDGE RESIN is a self-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials have sufficient physical properties to function in the oral cavity for up to 90 days and have 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: Luxatemp COMMON NAME: Temporary Crown and Bridge Resin CLASSIFICATION NAME: Temporary Crown and Bridge Resin (21 CFR 872.3770, Product code EBG)
| Cosmedent | LUXATEMP | |
|---|---|---|
| EQUIVALENTS | TEMPORARY C & B FillingMaterial | TemporaryFilling Material |
| Similarities | ||
| Intended Use | Both products have identical intended uses as temporary crown andbridge filling materials | |
| Composition | Both products have substantially the same chemical composition.They are self-cure, silica filled, difunctional acrylic composites | |
| Physical properties | Both products have similar physical and mechanical properties asshown in Table I below | |
| How supplied and used | Both products are supplied as auto-mix systems. Preloaded syringesare mixed and dispensed in a hand-gun and the mixed material iseither loaded into an impression and placed in the patient's mouth orthe product is applied directly on the prepared tooth. | |
| Mechanical and Physical Properties | CosmedentTEMPORARY C & B FillingMaterial | LUXATEMPTemporaryFilling Material |
| Compressive strength | 225 MPa | 220 MPa |
| Flexural strength | 82 MPa | 92 MPa |
| Percent filler by weight | 46 | 44 |
| Radiopaque | Yes | Yes |
| Differences | ||
| Attachment pickup use | No | Yes |
SUBSTANTIAL EQUIVALENCE SUMMARY
Submitted by: James L. Sandrik, PhD Cosmedent, Inc. 401 N. Michigan Ave. Suite 2500 Chicago, IL 60611
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 16 2005
James L. Sandrik, PhD Director of Regulatory Affairs Cosmedent, Incorporated 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611
Re: K060881
Trade/Device Name: Temporary Crown and Bridge Resin Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: March 29, 2006 Received: March 31, 2006
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 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 may publish further announcements concerning your device in the Eederal 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 Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
itte of Michael Oma
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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Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 510(k) submission for Temporary CROWN AND BRIDGE Resin
Page 5 of 17
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: MULTIPLE (TEMPORARY CROWN AND BRIDGE RESIN )
Indications For Use:
Temporary CROWN AND BRIDGE Resin is indicated for use as a temporary restorative material for crown and bridge, inlay, and/or onlay restorations.
Prescription Use X (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 Runner
1 : - ( : ) Tot Anonihesiology, General Hospital, on Control, Cantal Devices
06088
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.