CORERESTORE 2

K011798 · Sybron Dental Specialties, Inc. · EBF · Aug 14, 2001 · Dental

Device Facts

• Record ID: K011798
• Device Name: CORERESTORE 2
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBF · Dental
• Decision Date: Aug 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Corerestore 2 is a fluoride releasing, resin-based material designed to be used for composite core build-ups. Corerestore 2 can be used in either the dual cure, two part base/catalyst configuration or in the light cure, one part paste configuration.

Device Story

Corerestore 2 is a fluoride-releasing, resin-based composite material used for core build-ups in dental restorations. The device is available in two configurations: a dual-cure, two-part base/catalyst system or a light-cure, one-part paste system. It is offered in both high and low viscosities. The material is applied by dental professionals in a clinical setting to build up tooth structure prior to final restoration. By providing a stable, fluoride-releasing foundation, it facilitates the restorative process and supports long-term tooth health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fluoride-releasing resin-based composite material. Available in dual-cure (base/catalyst) or light-cure (one-part paste) configurations. Offered in high and low viscosities. Class II device under 21 CFR 872.3690.

Indications for Use

Indicated for composite core build-ups in patients requiring dental restorative procedures.

Regulatory Classification

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.

Predicate Devices

• Jeneric/Pentron, Inc, Build-It
• Kuraray Co., Ltd., Clearfil Photo Core

Submission Summary (Full Text)

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AUG 1 4 2001

1 20

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 curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font.

### SYBRON DENTAL SPECIALTIES

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

#### Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summarv Prepared: June 2001

#### Device Name:

- Trade Name Corerestore 2 .
- Common Name Composite Core Build-up Material .
- Classification Name Tooth shade resin material, per 21 CFR § 872.3690 .

#### Devices for Which Substantial Equivalence is Claimed:

- . Jeneric/Pentron, Inc, Build-It
- Kuraray Co., Ltd., Clearfil Photo Core .

#### Device Description:

Corerestore 2 is a fluoride released core build-up material. Corerestore 2 can be used in either the dual cure, two part base/catalyst configuration or in the light cure, one part paste configuration. The product is available in both, high and low viscosities.

#### Intended Use of the Device:

The intended use of Corerestore 2 is for composite core build-ups.

#### Substantial Equivalence:

Corerestore 2 is substantially equivalent to other legally marketed devices in the United States. The resin based composite core build-up materials marketed by Jeneric/Pentron, Inc. and Kurary Co., Ltd. function in a manner similar to and are intended for the same use as the product manufactured by Kerr Dental Materials Center.

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Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 1 4 2001

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

K011798 Re : Trade/Device Name: Corerestore 2 872.3690 Requlation Number: Regulatory Class: II Product Code: EBF Dated: June 6, 2001 Received: June 8, 2001

Dear Ms. Boswell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marice 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). 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements

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Page 2 - Ms. Boswell

concerning your device in the Federal Register. Please note: concerning your device in enter in entification submission does this response to your promobility have under sections 531 not arrect any obrigation four devices under the Electronic Chrough 542 Of the Act 101 xeviews, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as mis recei wasn't (k) premarket notification. The FDA described in your srown promience of your device to a legally Linding of Subscancial equired in a classification for your marketed predicate device rebared in opened to the market.

If you desire specific advice for your device on our labeling i If you debire bport 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on Compliance at (501) Seertising of your device, please contact che promocron and adversibility on Journal (1301) please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers obtained from the Division Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Patricia Cucenita/for

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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## Section I

# Indications for Use Statement

| Ver/3-4/24/96 |
|---------------|
|---------------|

| Applicant: | Kerr Dental Material Center |
|---------------------------|-----------------------------|
| 510(k) Number (if known): | K011798 |
| Device Name: | Corerestore 2 |
| Indications For Use: | |

Corerestore 2 is a fluoride releasing, resin-based material designed to be used for composite core build-ups. Corerestore 2 can be used in either the dual cure, two part base/catalyst configuration or in the light cure, one part paste configuration.

| | <i>Gerald W. Shigekawa</i> | <i>for MSR</i> |
|---------------|---------------------------------------------------------------------|----------------|
| | (Division Sign-Off) | |
| | Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K011798 | |

(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)

ary