BelleGlass Dual Cure Enamel Repair Resin is indicated for use with the BelleGlass HP Heat + Pressure Cure Composite Crown and Bridge Fabrication System when it is necessary to perform minor adjustments or repairs to an appliance during the fabrication procedure.

Device Description

BelleGlass HP Dual Cure Enamel Repair Material is a reformulation of the heat + pressure cure material to allow the material to be light cured so that it is more stable during the transfer to the Heat + Pressure Curing Device. A very small amount of photoinitiating agent ( < 1 % ) was added to the formula and the directions will be rewritten to include the light cure step when using the enamel repair materials.

AI/ML Overview

The provided text discusses the BelleGlass HP Enamel Repair Material, a dental product, and its reformulation into the BelleGlass HP Dual Cure Enamel Repair Material. The document is a 510(k) summary for a medical device, focusing on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided, noting that much of the requested information (especially regarding clinical study methodology, ground truth establishment, and multi-reader studies) is not applicable or not explicitly detailed for this type of device and submission. This is a material modification that relies on bench testing and biocompatibility assessments, rather than large-scale clinical trials often associated with AI/diagnostic devices.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria (Stated/Implied)	Reported Device Performance
Safety	Biocompatibility in accordance with ISO 10993 (Cytotoxicity & Mutagenicity)	"The reformulated product was reexamined using two of the test protocols specified in the ISO 10993 Biocompatibility Testing Guidance Standard." - Cytotoxicity: Agar Diffusion Test USP - Mutagenicity: Salmonella Typhimurium REVERSE MUTATION ASSAY (Ames Test)
Efficacy/Performance	Performs "as well or better than" the current heat and pressure cured material for its intended purpose.	"Results of this bench testing indicates that the dual cure material performs as well or better than the heat + pressure cured material." (Actual results provided elsewhere in the submission, not in this excerpt).
Intended Use	Indicated for minor adjustments or repairs to appliances during fabrication in conjunction with the BelleGlass HP system.	"BelleGlass Dual Cure Enamel Repair Resin is indicated for use with the BelleGlass HP Heat + Pressure Cure Composite Crown and Bridge Fabrication System when it is necessary to perform minor adjustments or repairs to an appliance during the fabrication procedure."
Substantial Equivalence	Equivalent to the predicate device (BelleGlass HP Heat and Pressure Cure Enamel Repair Material).	FDA determined the device is "substantially equivalent" to devices marketed prior to May 28, 1976.

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

Test Set Sample Size: Not explicitly stated. The "testing consisted of the following" refers to a biological and efficacy evaluation, not a patient-based test set in the conventional sense. For the biocompatibility tests (Cytotoxicity and Mutagenicity), the sample sizes would be described by the specifics of those assays, which typically involve cell cultures and bacterial colonies. For the efficacy bench testing, the number of samples (e.g., repaired appliances, test specimens) is not provided.
Data Provenance: The biocompatibility testing was performed by "Independent Laboratory Evaluation by Toxicon Corporation." The efficacy testing was "bench testing." No country of origin for specific "data" is mentioned, as it primarily involves laboratory and bench studies. It is a prospective evaluation of the reformulated product.

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

Not applicable in the context of this submission. This is a material science and biocompatibility assessment, not a diagnostic device requiring expert interpretation for "ground truth" in clinical images or similar data. The ground truth for biocompatibility is established by the standardized protocols of the tests themselves (USP Agar Diffusion Test, Ames Test). The efficacy "ground truth" would be based on measurable material properties and performance against specified criteria in a lab setting, validated by material scientists or engineers, but no specific "experts" for ground truth establishment are mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this is not a diagnostic imaging or clinical interpretation study, no adjudication method like 2+1 or 3+1 (which are common in expert consensus for medical image interpretation) would be used. The biocompatibility tests have objective endpoints, and the efficacy bench tests would rely on established measurement protocols.

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

No. An MRMC comparative effectiveness study is not mentioned and is not relevant for this type of dental material modification submission. This study design is typically used for diagnostic devices, especially those incorporating AI, to assess radiologists' or other clinicians' performance with and without AI assistance.

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

No. This is not an AI/algorithm-based device. "Standalone performance" is not a relevant concept here. The device itself (a repair material) is a physical product, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Biological Endpoints for Safety: For biocompatibility, the ground truth is based on the objective results of standardized in-vitro tests:
- Cytotoxicity: Cell viability/response as per USP Agar Diffusion Test.
- Mutagenicity: Bacterial mutation rates as per Salmonella Typhimurium REVERSE MUTATION ASSAY (Ames Test).
Bench Testing Results for Efficacy: For efficacy, the ground truth would be based on measured material properties and performance characteristics (e.g., strength, flow, stability, cure characteristics) as compared to the predicate device in a laboratory setting. No "expert consensus" or "pathology" in the diagnostic sense is mentioned.

8. The sample size for the training set

Not applicable. This device is a material, not a machine learning model, so there is no "training set" in the context of AI or algorithm development. The development process would involve formulation, lab testing, and refinement, but not in the sense of training a model with data.

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

Not applicable. As there is no training set for an AI model, this question does not apply.

Summary

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Ka7176a

SEP 1 2 1997

Page 1 of 2

510 ( k ) Summary

Statement of Safety an Effectiveness

BelleGlass HP Enamel Repair Material

Submitter

Sybron Dental Specialties Inc. 1717 West Collins Avenue Orange, CA 92867 (714) 516-7486 - Phone (714) 516-7488 - FAX William R. Pike - Contact Person

Device Name

Trade Name: BelleGlass HP Enamel Repair Material Common Name: Dual Cured Composite Crown and Bridge Fabrication Material Classification Name: Tooth shade resin material, Class II, 21 CFR 872.3690

Devices for which Substantial Equivalence is Claimed

BelleGlass HP Heat and Pressure Cure Enamel Repair Material ( Kerr Corporation )

BACKGROUND

Kert/Dental Materials Center currently manufactures a product marketed under the Tradename BelleGlas HP Dental Laboratory Crown and Bridge Fabrication System ( 510 ( k ) Reference K95533) ). It is used in commercial dental laboratories to fabricate composite based crowns and bridgework. This product has been on the market since March, 1996. A component material in the current product is a heat + pressure cured enamel repair to be used for minor adjusments or repairs to appliances damaged during processing. BelleGlass Dual Cure Enamel Repair Material is simply a reformulation of the heat and pressure cure material to allow the material to be light cured so that it is more stable during the transfer to the Heat + Pressure Curing Device. This is a product modification based on requests from customers for a more durable, with respect to paste deformation and flow, during the transfer procedure.

BelleGlass HP Dual Cure Enamel Repair Material

A very small amount of photoinitiating agent ( < 1 % ) was added to the formula and the directions will be rewritten to include the light cure step when using the enamel repair materials.

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SAFETY

The reformulated product was reexamined using two of the test protocols specified in the ISO 10993 Biocompatibility Testing Guidance Standard.

The testing consisted of the following:

Independent Laboratory Evaluation by Toxicon Corporation

A.) Cytotoxicity: Agar Diffusion Test USP
B.) Mutagenicity: Salmonella Typhimurium REVERSE MUTATION ASSAY ( Ames Test )

EFFICACY

Effectiveness or suitability to the intended purpose of BelleGlass HP Dual Cure Enamel Repair Material has been demonstrated by side test comparisons to the current heat and prssure cure enamel repair material. Results of this bench testing indicates that the dual cure material performs as well or better than the heat + pressure cured material. Actual results of this comparative testing is provided elsewhere in this submission.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 1997

Mr. William R. Pike Requlatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92667

Re : K971762 Trade Name: Belleqlass HP Enamel Repair Material Regulatory Class: II Product Code: EBF Dated: July 17, 1997 Received: July 21, 1997

Dear Mr. Pike:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Pike

through 542 of the Act for devices under the Electronic through 542 of the Act 101 xevisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as This letter will allow you co begin motification. The FDA described in your 510 (x) promalence of your device to a legally I marketed predicate device results in a classification for your marketed predicate device robates as a proceed to the market.

If you desire specific advice for your device on our labeling II you desire bpcorris and additionally 809.10 for in regulacion (21 or origins), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on Compilance at (301) 554 - 1010. Insuredevice, please contact the Dromotion and adversions (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation chercless, "ABFR 807.97) , Other general premation on your responsibilities under the Act may be firstmacion on Journal Manufacturers Assistance obcained from the bivibical 02 638-2041 or (301) 443-6597 or at at its coll-free number (000) 030 fda.gov/cdrh/dsmamain.html".
its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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Page I of 1

510 ( k ) Number : K 971762

Device Name : BelleGlass Dual Cure Enamel Repair Resin

Indications For Use : BelleGlass Dual Cure Enamel Repair Resin is indicated for use with the BelleGlass HP Heat + Pressure Cure Composite Crown and Bridge Fabrication System when it is necessary to perform minor adjustments or repairs to an appliance during the fabrication procedure.

Concurrence of CDRH, Office of Device Evaluation

Swoer Ranner

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

prescription use Yes

ver-The-Counter use No

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.