(44 days)
Not Found
No
The device is a chemical bonding agent and the summary contains no mention of AI, ML, or related concepts.
No.
The device is used to bond denture components, not to treat a disease or condition.
No
The device is described as a bonding agent used to attach denture components, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "polymer/ monomer liquid solution," indicating it is a chemical substance, 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 to bond plastic denture teeth and reline materials to acrylic denture bases. This is a mechanical function performed on a medical device (denture), not a diagnostic test performed on a biological sample from the human body.
- Device Description: The device is a polymer/monomer liquid solution used for bonding. This aligns with a material used in the fabrication or repair of a medical device, not a reagent or instrument used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Using techniques like immunoassays, molecular diagnostics, or clinical chemistry.
The performance study described focuses on the residual monomer content in the denture material, which is relevant to the safety and quality of the denture itself, not a diagnostic measurement related to a patient's health.
Therefore, TRUBYTE® DENTURE BOND Denture Bonding Agent is a dental material used in the fabrication or repair of dentures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TRUBYTE® DENTURE BOND Denture Bonding Agent is used to bond plastic denture teeth and denture reline materials to acrylic denture bases.
Product codes
EBI
Device Description
TRUBYTE® DENTURE BOND Denture Bonding Agent is a polymer/ monomer liquid solution. It is compatible with both heat-cured and auto-polymerizable acrylic denture base resins.
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)
Gas chromatographic analysis of the residual methyl methacrylate monomer in denture samples was conducted to determine the effect that TRUBYTE® DENTURE BOND Denture Bonding Agent use would have on the residual monomer content in a denture. There is not a statistically significant difference in residual monomer between samples that utilized TRUBYTE® DENTURE BOND Denture Bonding Agent vs. those prepared without bonding agent. This analysis confirms that TRUBYTE® DENTURE BOND Denture Bonding Agent use does not affect the amount of residual monomer present in the denture base.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
.111 22 1998
DENTSPLY
510(k) SUMMARY
DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 717) 845-7511
NAME & ADDRESS:
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
DATE PREPARED: June 4, 1998
TRADE OR PROPRIETARY NAME: TRUBYTE® DENTURE BOND Denture Bonding Agent
872.3200 CLASSIFICATION NAME: Resin tooth bonding agent
K924422 Palabond® Adhesion Primer PREDICATE DEVICES:
DEVICE DESCRIPTION: TRUBYTE® DENTURE BOND Denture Bonding Agent is a polymer/ monomer liquid solution. It is compatible with both heat-cured and auto-polymerizable acrylic denture base resins.
INTENDED USE: TRUBYTE® DENTURE BOND Denture Bonding Agent is used to bond plastic denture teeth and denture reline materials to acrylic denture bases.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in TRUBYTE® DENTURE BOND Denture Bonding Agent have been used in legally marketed medical devices.
Gas chromatographic analysis of the residual methyl methacrylate monomer in denture samples was conducted to determine the effect that TRUBYTE® DENTURE BOND Denture Bonding Agent use would have on the residual monomer content in a denture. There is not a statistically significant difference in residual monomer between samples that utilized TRUBYTE® DENTURE BOND Denture Bonding Agent vs. those prepared without bonding agent. This analysis confirms that TRUBYTE® DENTURE BOND Denture Bonding Agent use does not affect the amount of residual monomer present in the denture base. Accordingly, no additional patient risk is associated with the use of TRUBYTE® DENTURE BOND Denture Bonding Agent on dentures properly processed with Lucitone® 199 or Lucitone® FasPor+™ pourable denture base.
We believe that the prior use of the components of TRUBYTE® DENTURE BOND Denture Bonding Agent in legally marketed predicate devices, and the performance and safety data provided, support the safety and effectiveness of TRUBYTE® DENTURE BOND Denture Bonding Agent for the indicated uses.
00013
1
Image /page/1/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line.
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
JUL 22 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. P. Jeffrey Lehn ·Associate Director Corporate Compliance DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17404
Re: K982007 TRUBYTE® DENTURE BOND Denture Bonding Agent Trade Name: Requlatory Class : II Product Code: EBI June 4, 1997 Dated: Received: June 8, 1997
Dear Mr. Lehn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Lehn
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
S. Butman Jr
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109)
510(K) Number:
Device Name:
TRUBYTE® DENTURE BOND Denture Bonding Agent
TRUBYTE® DENTURE BOND Denture Bonding Agent is used to bond plastic denture teeth and denture reline materials to acrylic denture bases.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Susan Russo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Pevice 510(k) Number_
000007