(9 days)
Not Found
No
The summary describes a system of light-cured resins for fabricating dentures, focusing on material properties and a simplified manufacturing process. There is no mention of AI, ML, image processing, or data-driven analysis.
No.
The device is used for the fabrication and repair of dentures and appliances, which are restorative rather than therapeutic in nature.
No
The device is a system of resins used for the fabrication, repair, and relining of dentures, appliances, and prostheses. Its intended use is for construction and repair, not for diagnosing medical conditions.
No
The device description clearly states it is composed of five resin formulations and describes a process involving light curing and the construction of a physical denture base. This indicates a physical material and manufacturing process, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication, repair, and relining of dentures, appliances, and prostheses. This is a direct interaction with the patient's body (or a physical representation of it) for a structural purpose, not for analyzing a sample taken from the body to diagnose a condition.
- Device Description: The description details a system of resins used to build a physical dental appliance. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring biomarkers or analytes
- Using reagents or assays
IVDs are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Trubyte® Denture Base Resin System is a material used to create a physical dental device.
N/A
Intended Use / Indications for Use
The Trubyte® Denture Base Resin System is indicated for:
-
- Fabrication of dentures, appliances and prostheses
-
- Repair of dentures, appliances and prostheses
-
- Relining of denture surfaces
These are the same Indications for Use as previously cleared for K011560.
Product codes
EBI
Device Description
The TRUBYTE® DENTURE BASE RESIN SYSTEM is composed of five resin formulations: a denture baseplate resin, contour resin, clear resin, clear resin, and resilient resin. The finished denture base is constructed from a laminate of these resins that are light cured. These new materials bypass the usual "lost wax" process and allow the dentist and technician to develop a trial denture that will become the final denture. It will not be necessary to fabricate a mold or "invest" the trial denture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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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
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Summary of Performance Studies
The TRUBYTE® DENTURE BASE RESIN SYSTEM resilient resin, uncured and cured, have been evaluated and passed biocompatibility testing for cytotoxicity, mutagenicity, irritation, and sensitization.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a close-up of a textured, dark surface that curves along the top and right side, contrasting with a bright white background. The texture appears granular and dense, creating a stark visual contrast between the dark, rough area and the smooth, empty space. The curve suggests the edge of a three-dimensional object or a portion of a larger design.
510(k) SUMMARY
NAME & ADDRESS:
DENTSPLY
SEP 2 6 2003
ITSPLY Internationa 70 West College Avenue O Box 872 York, PA 17405-0872 717) 845-7511 ax 17-77-849-4762 www.dentsply.com
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
September 16, 2003 DATE PREPARED:
TRADE OR PROPRIETARY NAME: Trubyte® Denture Base Resin System
CLASSIFICATION NAME: Relining, Repairing, and Rebasing Resin 872.3670
PREDICATE DEVICES: Trubyte® Denture Base Resin System (K011560)
DEVICE DESCRIPTION: The TRUBYTE® DENTURE BASE RESIN SYSTEM is composed of five resin formulations: a denture baseplate resin, contour resin, clear resin, clear resin, and resilient resin. The finished denture base is constructed from a laminate of these resins that are light cured. These new materials bypass the usual "lost wax" process and allow the dentist and technician to develop a trial denture that will become the final denture. It will not be necessary to fabricate a mold or "invest" the trial denture.
INTENDED USE: 1) Fabrication of dentures, appliances and prostheses; 2) Repair of dentures, appliances and prostheses; and 3) Relining of denture surfaces
TECHNOLOGICAL CHARACTERISTICS: All of the components found in the Resins of the TRUBYTE® DENTURE BASE RESIN SYSTEM have been used in legally marketed devices or were found safe for dental use.
The TRUBYTE® DENTURE BASE RESIN SYSTEM resilient resin, uncured and cured, have been evaluated and passed biocompatibility testing for cytotoxicity, mutagenicity, irritation, and sensitization.
We believe that the prior use of the components of TRUBYTE® DENTURE BASE RESIN SYSTEM in legally marketed devices and the biocompatibility data provided support the safety and effectiveness of TRUBYTE® DENTURE BASE RESIN SYSTEM for the indicated uses.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three lines representing the snakes and a central element representing the staff.
Public Health Service
SEP 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K032892
Trade/Device Name: Trubyte® Denture Base Resin System Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: September 16, 2003 Received: September 17, 2003
Dear Mr. Lehn:
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.
2
Page 2 – Mr. P. Jeffery Lehn
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 (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.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Susan Runner, DDS, MA Interim 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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INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(c)
510(K) Number (if known): K032992
Device Name: Trubyte® Denture Base Resin System
Indications for Use:
The Trubyte® Denture Base Resin System is indicated for:
-
- Fabrication of dentures, appliances and prostheses
-
- Repair of dentures, appliances and prostheses
-
- Relining of denture surfaces
These are the same Indications for Use as previously cleared for K011560.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
R.Shetz DDS or Dr. K. Mulin
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K032892