TEMP-BOND NE 2

K003658 · Sybron Dental Specialties, Inc. · EMA · Jan 4, 2001 · Dental

Device Facts

• Record ID: K003658
• Device Name: TEMP-BOND NE 2
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EMA · Dental
• Decision Date: Jan 4, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

The intended use of Temp-Bond NE 2 is for the cementation of temporary restorations.

Device Story

Temp-Bond NE 2 is a non-eugenol temporary dental cement. It is a two-part, base/catalyst paste system. The device is used by dental professionals for the cementation of temporary restorations. Its formulation is designed to avoid inhibiting the setting of permanent resin cements and to prevent softening of acrylic temporary restorations. It serves as an alternative for patients with eugenol allergies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Two-part, base/catalyst paste/paste system. Non-eugenol formulation. Dental cement.

Indications for Use

Indicated for the cementation of temporary restorations in patients with eugenol allergies.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• Kerr Corporation, Temp-Bond NE

Submission Summary (Full Text)

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K003658

JAN - 4 2001

Image /page/0/Picture/2 description: The image shows a logo for "sds Kerr Sybron Dental Specialties". The logo is black and white and features the text "sds Kerr" in a bold, sans-serif font. The text "SYBRON DENTAL SPECIALTIES" is below the main text in a smaller font. There is a curved line above the text, which is part of the logo design.

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 Summary Prepared: November 2000

### Device Name:

- Trade Name Temp-Bond NE 2 .
- Common Name - Temporary Dental Cement
- Classification Name Dental Cement Other Than Zinc-Oxide Eugenol, per 21 CFR & . 872.3275 (b)

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

- . Kerr Corporation, Temp-Bond NE
## Device Description:

The device is a non-eugenol temporary cement that is used for the cementation of temporary restorations. Temp-Bond NE 2 is a two-part, base/catalyst - paste/paste system. The product will not inhibit the set of permanent resin cements or soften acrylic temporary restorations. Temp-Bond NE 2 is indicated for patients who are allergic to eugenol.

#### Intended Use of the Device:

The intended use of Temp-Bond NE 2 is for the cementation of temporary restorations.

# Substantial Equivalence:

Temp-Bond NE 2 is substantially equivalent to other legally marketed devices in the United States. The modified formulation of Temp-Bond NE functions in a manner identical to and is intended for the same use as the original Temp-Bond NE formula currently manufactured by Kerr Corporation.

> 1717 West Collins Avenue, Orange, (AS2867 800-KERRI23 714-516-7400

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is a stylized image of an eagle.

JAN - 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K003658 Temp-Bond NE 2 Trade Name: Requlatory Class: II Product Code: EMA Dated: November 22, 2000 November 28, 2000 Received:

#### Dear Ms. Boswell:

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 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 requlations 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 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 through 542 of the Act for devices under the Electronic

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Page 2 - Ms. Boswell

Product Radiation Control provisions, or other Federal laws or regulations.

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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers "Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

.

Sincerely yours.

Timotheus Hlabiskin

Ulatowski Timo Directo 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

510(k) Number:

K003658

Device Name: Temp-Bond NE 2

Indications for Use:

Temp-Bond NE is a non-eugenol temporary cement used for the cementation of temporary restorations.

Susan Rumser

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Pr 0036 ビイC(k) Number _