(161 days)
None
Not Found
No
The summary describes a self-curing acrylic resin for dental applications and contains no mention of AI or ML.
No
The device is an acrylic resin used for dental applications like constructing temporary inlays, crowns, and bridges, and repairing dentures. It does not directly treat or prevent a disease or condition.
No
The device is described as an acrylic resin used for dental applications like constructing temporary inlays, crowns, and bridges, and repairing fractured dentures. These are restorative or fabrication functions, not diagnostic ones.
No
The device description clearly states it is a self-curing acrylic resin, which is a physical material, not software.
Based on the provided information, Unifast III is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the device as a self-curing acrylic resin for dental applications like temporary restorations and denture repair. This is a direct application to the patient's mouth or a dental appliance, not for testing samples taken from the body.
- Device Description: The description confirms it's an acrylic resin, consistent with a material used in dental procedures.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, Unifast III falls under the category of a dental material used for restorative and repair purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Unifast III is a self-curing acrylic resin used for a variety of dental applications, including construction of temporary inlays, crowns and bridges and repair of fractured dentures in either pressure or paint on techniques.
Product codes
EBI, EBG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mark Heiss D.D.S. Director, Professional Relations & Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
APR 11 2008
Re: K073106
Trade/Device Name: Unifast III Regulation Number: 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI, EBG Dated: March 19, 2008 Received: March 24, 2008
Dear Dr. Heiss:
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 Federal Register.
1
Page 2 - Dr. Heiss
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" (21CFR 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.
Chiu-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K073106
Device Name: Unifast III
Indications for Use: Unifast III is a self-curing acrylic resin used for a variety of dental applications, including construction of temporary inlays, crowns and bridges and repair of fractured dentures in either pressure or paint on techriiques.
Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page ___ of __________________________________________________________________________________________________________________________________________________________________
Swser Summe
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: X673101