belleGlass HP Enamel 2 is a dual cured composite material for use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges.

Device Description

belleGlass HP Enamel 2 is dual cured composite material for use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. The belleGlass HP crown and bridge fabrication system is comprised of a!! 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.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a dental restorative material, "belleGlass HP Enamel 2." This document focuses on demonstrating substantial equivalence to a predicate device and securing market clearance from the FDA.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The information provided is for regulatory clearance based on substantial equivalence, not for a clinical or performance study demonstrating the device meets specific acceptance criteria in the way described in the prompt.

Therefore, I cannot extract the requested information from the provided text.

To answer your request, the document would need to include details of a study that measured specific performance metrics (e.g., wear resistance, bond strength, flexural strength) for belleGlass HP Enamel 2, compared these metrics against predefined acceptance criteria, and provided details on the study design, data, and analysis.

Summary

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OCT - 1 2001

Image /page/0/Picture/1 description: The image is a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized, bold font, with a swooping line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, blocky font.

K013007

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 Enamel 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 Enamel .

Device Description:

belleGlass HP Enanel 2 is dual cured composite material for use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. The belleGlass HP crown and bridge fabrication system is comprised of a!! 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.

Intended Use of the Device:

The intended use of belleGlass HP Enamel 2 is for use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges.

Substantial Equivalence:

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

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 1 2001

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

Re: K013007

Trade/Device Name: Belleglass HP Enamel 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 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.

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 1 od intilet comply was 807); labeling (21 CFR Part 801); good manufacturing practice and instills (21 er read 001), systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.

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 promation received 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 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 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,

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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KO13007

Section I

Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Kerr Dental Materials Center

510(k) Number (if known):
K013007

Device Name: belleGlass HP Enamel 2

Indications For Use:

belleGlass HP Enamel 2 is a dual cured composite material for use with the belleGlass HP (heat
and pressure) crown and bridge fabrication system to produce high wear resistance and
permanent surface luster for composite crowns and bridges.

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K013007

(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.