TRUBYTE DENTURE BOND DENTURE BONDING AGENT by DENTSPLY INTL.

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.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria (Stated Goal)	Reported Device Performance
Not affect the amount of residual monomer present in the denture base	"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."

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not explicitly stated. The text mentions "denture samples" but does not provide a specific number.
Data provenance: Not explicitly stated, but the study was conducted by DENTSPLY International as part of their 510(k) submission. It's likely a prospective study conducted in a lab setting, but this is an inference. There's no information on the country of origin of the data beyond DENTSPLY's location (York, PA, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not applicable. The ground truth was established through a quantitative chemical analysis (Gas chromatographic analysis).
Qualifications of experts: Not applicable.

4. Adjudication method for the test set:

Adjudication method: Not applicable. The ground truth was established through a quantitative chemical analysis, not expert review.

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:

MRMC study: No, this type of study was not performed. The device is a bonding agent, not an AI-assisted diagnostic tool.
Effect size: Not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone performance: No, this concept is not applicable. The device is a chemical bonding agent, not an algorithm. The performance evaluation was on the chemical properties of the material.

7. The type of ground truth used:

Type of ground truth: Quantitative chemical measurement (Gas chromatographic analysis of residual methyl methacrylate monomer).

8. The sample size for the training set:

Sample size for training set: Not applicable. The device is a chemical product, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established:

How ground truth for training set was established: Not applicable.

Summary

{0}------------------------------------------------

.111 22 1998

K982667

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.

{2}------------------------------------------------

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:

K982007

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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Susan Russo

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Pevice 510(k) Number_

000007

Regulation Number and Section

§ 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.