NIVEOUS LIQUID DAM

K021613 · Shofu Dental Corp. · EIE · Jun 20, 2002 · Dental

Device Facts

• Record ID: K021613
• Device Name: NIVEOUS LIQUID DAM
• Applicant: Shofu Dental Corp.
• Product Code: EIE · Dental
• Decision Date: Jun 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6300
• Device Class: Class 1

Intended Use

The Niveous Liquid Dam resin is indicated to protect soft tissue during in-office bleaching.

Device Story

Niveous Liquid Dam is a light-cured resin used for soft tissue isolation during in-office teeth whitening. Clinician dispenses resin from syringe onto gingival crest; material is light-cured for 20 seconds per section to polymerize and form protective barrier. Device serves as component of Niveous Professional Tooth Whitening System. Protects patient soft tissue from bleaching agents; prevents chemical irritation during procedure.

Clinical Evidence

No clinical data. Substantial equivalence supported by comparison of chemical composition and physical characteristics to predicate devices.

Technological Characteristics

Light-cured resin material. Delivered via syringe. Polymerization via light-curing (20 seconds per section).

Indications for Use

Indicated for protection of soft tissue during in-office tooth bleaching procedures.

Regulatory Classification

Identification

A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.

Predicate Devices

• FastDam (K972775)
• OpalDam (K971284)

Submission Summary (Full Text)

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JUN 2 0 2002

Image /page/0/Picture/1 description: The image shows a black circle with the word "SHOFU" in white, block letters across the center. The "R" in a circle, indicating a registered trademark, is located in the bottom right corner of the circle. The logo is simple and uses a contrasting color scheme to make the text stand out against the dark background.

DENTAL CORPORATION 5 Stone Drive, San Marcos, California 92069-4059 U.S.A. el.: [phone] • FAX.: [phone]

KQ21613

510(k) SUMMARY

| Submitted by: | Robert Noble, President<br>Shofu Dental Corporation<br>1225 Stone Drive<br>San Marcos, CA 92069-4059<br>[phone]<br>FAX: [phone] |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Robert Noble, President |
| Date Summary Prepared | May 14, 2002 |
| Trade Name | Niveous Liquid Dam |
| Common Name | Resin dam |
| Classification | EIE |
| Product Code | 872.6300 |
| Substantially Equivalent Devices | FastDam [510(k) Number - K972775]<br>OpalDam [510(k) Number - K971284] |

## Description of Niveous Liquid Dam

Niveous Liquid Dam is a light-cured resin used for soft tissue isolation/protection during teeth whitening procedures. The material is dispensed from a syringe into the gingival crest just shy of the tooth structure. The resin is light-cured (polymerized) on the soft tissue by exposure for 20 seconds per section of material.

## Intended Use:

The Niveous Liquid Dam resin is indicated to protect soft tissue during in-office bleaching.

Shofu Dental Corporation Niveous Liquid Dam 510(k) Summary

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Image /page/1/Picture/0 description: The image shows a black circle with the word "SHOFU" in white letters inside. The letters are bold and sans-serif. There is a horizontal line that runs through the middle of the word. The registered trademark symbol is located in the bottom right corner of the circle.

DENTAL CORPORATION ne Drive, San Marcos, California 92069-4059 U.S.A. ) 736-3277 • FAX .: [phone]

## Kit Components:

Niveous Liquid Dam is a component in the Niveous Professional Tooth Whitening System. The kit consists of the following components:

- 1. Syringe containing Niveous Liquid Dam
- 2. Bleach Gel Droplet
- 3. Booster Brush
- 4. Dappen Dish

## Biocompatibility

Niveous Liquid Dam is similar in use and formulation to other dental dams that have been on the market for several years. (Interdent Incorporated, FastDam 510(k) K972775, among others) The formulation does not contain any new or non-conventional chemicals; therefore, new biocompatibility testing is unwarranted.

## Nonclinical tests that support a determination of substantial equivalence

The chemical composition is comparable to FastDam, 510(k) K972775, and has the same physical and chemical characteristics.

### Conclusion

The Niveous Liquid Dam is substantially equivalent to other liquid dam resins such as FastDam 510(k) K972775 and OpalDam 510(k) K971284.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 2 0 2002

Mr. Robert Noble President Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92069-4059

Re: K021613

Trade/Device Name: Niveous Liquid Dam Regulation Number: 872.6300 Regulation Name: Rubber Dam and Accessories Regulatory Class: I Product Code: EIE Dated: May 14, 2002 Received: May 16, 2002

Dear Mr. Noble:

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 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, However, you are responsible for determining that the medical devices you use as components of the Niveous kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the Act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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. 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

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### Page 2 - Mr. Robert Noble

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 the labeling regulation (21 CFR Part 801 and additionally Part 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 the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 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 [phone] or [phone], 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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# INDICATIONS FOR USE

K021613.

510(k) Number (if known):

Device Name:

Niveous Liquid Dam

## Indications For Use:

The Niveous Liquid Dam resin is indicated to protect soft tissue during in-office bleaching.

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rump

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F : O(k) Number_ KOS-11-

(Optional Format (3-10-98)

Shofu Dental Corporation Niveous Liquid Dam 510(k) Premarket Notification