belleGlass HP DC Opaceous Dentin LCTE 2 is a dual cured composite material for use with the belleGlass HP (heat and pressure) crown and bridge fabrication system where a more durable base for composite crowns and bridges is desired.

Device Description

belleGlass HP DC Opaceous Dentin LCTE 2 is dual cured composite material for use with the belleGlass HP (heat and pressure) crown and bridge fabrication system where a more durable base for composite crowns and bridges is desired. The belleGlass HP crown and bridge fabrication system is comprised of all the components necessary for a dental laboratory to fabricate composite resin-based crowns and bridges and cure them using both light activation combined with a final heat and pressure curing cycle in the belleGlass HP automatic curing device. belleGlass HP was formulated to have a lower coefficient of thermal expansion to more closely match that of natural tooth dentin.

AI/ML Overview

The provided text is a 510(k) summary for a dental material (belleGlass HP DC Opaceous Dentin LCTE 2) and related FDA correspondence. It does not contain information about acceptance criteria, device performance metrics, or study designs typically associated with AI/ML-driven medical devices.

The document states that the device is "substantially equivalent" to a legally marketed predicate device, belleGlass HP DC Opaceous Dentin LCTE, based on having similar function and intended use. This means its safety and effectiveness are established by comparison to an already approved device, rather than through a new clinical performance study with specific acceptance criteria and detailed quantitative results as would be typically found for novel devices or AI/ML algorithms.

Therefore, I cannot provide the requested information about acceptance criteria and study details for areas like sample size, ground truth, expert qualifications, or MRMC studies because this type of information is not present in the provided text for this specific device.

If the prompt were for an AI/ML medical device, the following would be the expected information:

1. A table of acceptance criteria and the reported device performance:
Not applicable to this document. This would typically include specific metrics like sensitivity, specificity, accuracy, AUC, F1-score, or precision/recall with predefined thresholds the device needs to meet.

2. Sample size used for the test set and the data provenance:
Not applicable to this document. For an AI/ML device, this would detail the number of cases/patients in the test set, their demographic breakdown, and where the data originated (e.g., specific hospitals, countries, retrospective or prospective collection).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable to this document. For an AI/ML device, this would specify how many experts reviewed the test data to define the true labels, along with their specializations, years of experience, and certifications.

4. Adjudication method for the test set:
Not applicable to this document. For an AI/ML device, this would describe the process if multiple experts disagreed on the ground truth (e.g., 2+1 means two experts decide, and a third adjudicates disagreements; 3+1 means three experts decide, and one adjudicates disagreements).

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:
Not applicable to this document. This type of study demonstrates the clinical utility of an AI device by comparing human performance with and without AI assistance, quantifying the improvement in metrics like diagnostic accuracy or reading time.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable to this document. This refers to studies evaluating the AI algorithm's performance in isolation, without human intervention.

7. The type of ground truth used:
Not applicable to this document. For an AI/ML device, this would specify if ground truth was established by expert consensus, histology/pathology, long-term patient outcomes, or other definitive diagnostic methods.

8. The sample size for the training set:
Not applicable to this document. For an AI/ML device, this would be the number of cases/patients used to train the algorithm.

9. How the ground truth for the training set was established:
Not applicable to this document. For an AI/ML device, this would detail the method by which the true labels for the training data were determined, similar to the test set ground truth but often with less stringent adjudication for initial training.

Summary

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OCT - 3 2001

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font. The image is in black and white.

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: August 2001

Device Name:

Trade Name belleGlass HP DC Opaceous Dentin LCTE 2 .
Common Name Dual Cured Indirect Composite Restorative Material ●
Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 .

Devices for Which Substantial Equivalence is Claimed:

Kerr Corporation, belleGlass HP DC Opaceous Dentin LCTE .

Device Description:

Intended Use of the Device:

The intended use of belleGlass HP DC Opaceous Dentin LCTE 2 is for use with the belleGlass HP (heat and pressure) crown and bridge fabrication system where a more durable base for composite crowns and bridges is desired.

Substantial Equivalence:

belleGlass HP DC Opaceous Dentin LCTE 2 is substantially equivalent to other legally marketed devices in the United States. belleGlass HP DC Opaceous Dentin LCTE 2 functions in a manner similar to and is intended for the same use as the original belleGlass HP DC Opaceous Dentin LCTE formulation that is currently manufactured by Kerr Corporation.

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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three curved lines that resemble a caduceus or a symbol of health and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 2001

Ms. Colleen Boswell Director, Corporate Compliance Syrbon Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K013009

Trade/Device Name: BelleGlass HP DC Opaceous Dentin LCTE 2 Regulation Number: 872.3690 Regulation Name: Dual Cured Indirect Composite Restorative Material Regulatory Class: II Product Code: EBF Dated: August 31, 2001 Received: September 6, 2001

Dear Ms. Boswell:

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 (1 Mr.), It ind ) 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.

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.

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Page 2 - Ms. Boswell

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Ky. Williart

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO13009

Section I

Indications for Use Statement

Ver/3-4/24/96

ental Materials

510(k) Number (if known):

evice Name: belleGlass HP DC Opaceous Dentin LCTE 2

Indications For Use:

Susan Russo

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109) (Optional Format 1-2-96)

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.