(46 days)
Not Found
Not Found
No
The summary describes a self-cure composite resin material with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No
A therapeutic device is one that treats or cures a disease or condition. This device is described as a "temporary restorative material" and its intended use is for "temporary crown and bridge, inlay, and/or onlay restorations," which implies a restorative rather than a therapeutic function.
No
The device is described as a temporary restorative material for dental work, not for diagnosing conditions.
No
The device description clearly states it is a "self-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers," 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 as a temporary restorative material for dental restorations (crowns, bridges, inlays, onlays). This is a direct treatment/restoration function within the oral cavity.
- Device Description: The description details the material composition and its physical properties for use in the mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for a restorative purpose.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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
§ 872.3770 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.
0
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 Filling | |
| Material | Temporary | |
| Filling Material | ||
| Similarities | ||
| Intended Use | Both products have identical intended uses as temporary crown and | |
| bridge 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 as | |
| shown in Table I below | ||
| How supplied and used | Both products are supplied as auto-mix systems. Preloaded syringes | |
| are mixed and dispensed in a hand-gun and the mixed material is | ||
| either loaded into an impression and placed in the patient's mouth or | ||
| the product is applied directly on the prepared tooth. | ||
| Mechanical and Physical Properties | Cosmedent | |
| TEMPORARY C & B Filling | ||
| Material | LUXATEMP | |
| Temporary | ||
| Filling 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
1
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.
2
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
3
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