FIXAFLOSS

K071615 · Sybron Dental Specialties, Inc. · EEF · Sep 21, 2007 · Dental

Device Facts

• Record ID: K071615
• Device Name: FIXAFLOSS
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EEF · Dental
• Decision Date: Sep 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6300
• Device Class: Class 1

Intended Use

The intended use of the FixaFloss is to be placed between teeth for the fixation of rubber dams.

Device Story

FixaFloss consists of waxed dental floss integrated with silicone conical resilient clamping elements. Device functions as a rubber dam clamp; placed between teeth to secure rubber dam material during dental procedures. Packaged as a string of 20 cones in a hygienic dispenser with an integrated cutting blade. Used by dental professionals in clinical settings to facilitate isolation during dental work.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Waxed dental floss and silicone conical clamping elements. Form factor: String of 20 resilient cones in a dispenser with integrated cutting blade. Mechanical fixation principle.

Indications for Use

Indicated for use as a dental accessory to secure rubber dams between teeth during dental 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

• The Hygenic Corp., Wedjets

Submission Summary (Full Text)

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K071615

sds

SYBRON DENTAL SPECIALTIES

SEP 2 1 2007

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

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, CA 92867 714) 516-7484 -- Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: June 2007

# Device Name:

- Trade Name -- FixaFloss .
- . Common Name - Rubber Dam Clamp
- Classification Name Rubber dam clamp, 21 CFR § 872.6300 .

# Devices for Which Substantial Equivalence is Claimed:

- . The Hygenic Corp., Wedjets
# Device Description:

The FixaFloss is a waxed dental floss assembled with 1 size and 1 color silicone conical resilient clamping element packaged as a one string product containing 20 resilient connes in a hygienic dispenser with an integrated cutting blade.

#### Intended Use of the Device:

The intended use of the FixaFloss is to be placed between teeth for the fixation of rubber dams.

# Substantial Equivalence:

The FixaFloss is substantially equivalent to other legally marketed devices in the United States. The FixaFloss functions in a manner similar to and is intended for the same we as the Wedjets manufactured by The Hygenic Corp.

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SEP 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Colleen Boswell Vice President, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K071615

Trade/Device Name: FixaFloss Regulation Number: 21 CFR 872.6300 Regulation Name: Rubber Dam and Accessories Regulatory Class: I Product Code: EEF Dated: August 31, 2007 Received: September 4, 2007

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. Boswell

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 requirements as set forth in the quality systems (OS) 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]. 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 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/industry/support/index.html.

Sincerely yours,

Sus Runor

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Ko71615 510(k) Number (if known):

Device Name: FixaFloss

#### Indications for Use:

The FixaFloss is a waxed dental floss with a silicone conical clamping element intended to be placed between teeth for rubber dam fixation.

Prescription Use /

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Offician Sign Office of MAL

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Page 1 of 1