MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM by DENTSPLY INTL.

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.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the Trubyte® Denture Base Resin System. It's a regulatory submission to the FDA, not a study report detailing performance against acceptance criteria in the way a clinical trial or algorithm validation study would.

Therefore, the requested information elements (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC study, standalone performance, training set details) cannot be extracted from the provided text.

Here's why and what information can be inferred:

Key Takeaways from the Document:

Device Type: Trubyte® Denture Base Resin System (a light-cured resin system for dentures).
Regulatory Pathway: 510(k) Pre-market Notification, indicating a claim of substantial equivalence to a predicate device.
Predicate Device: Trubyte® Denture Base Resin System (K011560), implying the new system is an update or variant of an already cleared device.
Basis for Equivalence:
- The components of the new resin system have been used in legally marketed devices or found safe for dental use.
- Biocompatibility testing (cytotoxicity, mutagenicity, irritation, sensitization) was performed on the resilient resin (uncured and cured) and passed. This is the closest the document comes to experimental "acceptance criteria" and "performance."
Intended Use: Fabrication, repair, and relining of dentures, appliances, and prostheses. These are the same as the predicate device.

Why the Requested Information Cannot Be Provided from This Document:

Acceptance Criteria & Reported Performance Table: The document states that the resilient resin passed biocompatibility testing. It does not list specific numerical acceptance criteria (e.g., cytotoxicity index < X, irritation score < Y) or detailed quantitative results (e.g., cytotoxicity index = Z). It only offers a qualitative "passed."
Sample Sizes & Data Provenance: No information on the number of samples used for biocompatibility testing is provided, nor the source of any data beyond it being "biocompatibility data."
Number/Qualifications of Experts for Ground Truth: Not applicable. Biocompatibility testing typically involves in-vitro or in-vivo methodologies, not human expert consensus on diagnostic images or clinical outcomes.
Adjudication Method: Not applicable for biocompatibility testing.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating observer performance (e.g., radiologists, pathologists) with and without AI assistance for diagnostic tasks. This device is a material for manufacturing dentures, not a diagnostic tool.
Standalone Performance: While the biocompatibility testing evaluates the material itself (standalone), it's not a "standalone algorithm performance" in the context of AI/software.
Type of Ground Truth: The "ground truth" here is the outcome of standardized biocompatibility tests.
Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
How Ground Truth for Training Set Was Established: Not applicable.

In summary, this document is a regulatory submission demonstrating substantial equivalence for a dental material, relying on a history of safe use of its components and basic biocompatibility testing, not a detailed scientific study with the types of performance metrics and validation frameworks typically seen for software or diagnostic devices.

Summary

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510(k) SUMMARY

NAME & ADDRESS:

DENTSPLY

SEP 2 6 2003

K032892

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.

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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.

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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:

1. Fabrication of dentures, appliances and prostheses
1. Repair of dentures, appliances and prostheses
1. 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 __

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

Regulation Number and Section

§ 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.