STAND OUT

K031484 · Kerr Corp. · ELW · Jul 3, 2003 · Dental

Device Facts

• Record ID: K031484
• Device Name: STAND OUT
• Applicant: Kerr Corp.
• Product Code: ELW · Dental
• Decision Date: Jul 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Stand Out is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous and implant impression techniques.

Device Story

Stand Out is an addition-cure vinyl polysiloxane dental impression material; supplied as two-part base/catalyst paste/paste system; available in Wash and Tray viscosities. Used by dental professionals in clinical settings to capture anatomical impressions for crowns, bridges, edentulous arches, and implants. Material is applied to impression trays, placed in patient's mouth to set, and removed to create a negative mold of dental structures. Output serves as physical model for dental laboratory fabrication of restorations or prosthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Addition-cure vinyl polysiloxane dental impression material; two-part paste/paste system; available in Wash and Tray viscosities. Class II device per 21 CFR 872.3660.

Indications for Use

Indicated for dental patients requiring crown, bridge, edentulous, or implant impressions.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

• Dentsply Caulk, Aquasil UltraMonophase/Heavy/LV Smart Wetting Impression Material

Submission Summary (Full Text)

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

K031484

JUL 0 3 2003

## 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: May 2003

## Device Name:

- Trade Name Stand Out ●
- Common Name -- Dental Impression Material .
- Classification Name Impression Material, per 21 CFR & 872.3660 .

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

- Dentsply Caulk, Aquasil UltraMonophase/Heavy/LV Smart Wetting Impression . Material
#### Device Description:

The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous and implant impression techniques. Stand Out is a two-part, base/catalyst - paste/paste system. The product is available in two viscosities, Wash and Tray.

#### Intended Use of the Device:

The intended use of Stand Out is for all crowns and bridges, edentulous and implant impressions.

# Substantial Equivalence:

Stand Out is substantially equivalent to other legally marketed devices in the United States. Stand Out functions in a manner similar to and is intended for the same use as Aquasil UltraMonophase/Heavy/LV Smart Wetting Impression Material that is currently manufactured by Dentsply Caulk.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL 03 2003

Re: K031484

Trade/Device Name: Stand Out Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Codes: ELW Dated: May 08, 2003 Received: May 12, 2003

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.

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Page 2 – Ms. Colleen Boswell

Please be advised that FDA s issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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), 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 the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Kein Mchuy

Sa Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Section I - Indications for Use

Ver/ 3 - 4/24/96

Applicant: Kerr Corporation

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K031484 |
| Device Name: | Stand Out |

Indications For Use:

Stand Out is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous and implant impression techniques.

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| 510(k) Number. | K031484 |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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