OXY-GLIDE ROOT CANAL CLEANSER & LUB.

K992919 · Super Glide, Inc. · KJJ · Nov 19, 1999 · DE

Device Facts

• Record ID: K992919
• Device Name: OXY-GLIDE ROOT CANAL CLEANSER & LUB.
• Applicant: Super Glide, Inc.
• Product Code: KJJ · DE
• Decision Date: Nov 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Oxy Glide™ is used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy.

Device Story

Oxy Glide™ is a root canal cleanser and lubricant used during endodontic therapy. It contains urea peroxide, which releases oxygen upon contact with irrigation solutions (e.g., sodium hypochlorite). This oxygen bubbling action facilitates the removal of vital and necrotic pulp tissue, dentinal shavings, and debris from the root canal. The device is applied by a clinician during endodontic procedures. The physical properties, including viscosity, appearance, color, and odor, are similar to existing predicate products. The device is intended to be removed from the canal space following the cleansing process.

Clinical Evidence

No clinical data. Substantial equivalence is based on the established safety and efficacy of the predicate device, similarity in physical properties, and the known safety profile of the active ingredients used in dental applications.

Technological Characteristics

Root canal cleanser/lubricant containing urea peroxide. Physical properties (viscosity, appearance, color, odor) are equivalent to the predicate device. Designed for use with sodium hypochlorite irrigation. Non-electronic, chemical-based device.

Indications for Use

Indicated for chemical and mechanical cleansing of root canals during endodontic therapy in patients requiring root canal preparation.

Predicate Devices

• RC-PREP (Pre-1976 Device)

Submission Summary (Full Text)

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NOV 1 9 1999

## 510(k) Summary

Super Glide. Incorporated

Name & Address:

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Super Glide. Inc. 225 Colchester Avenue Burlinaton. VT 05401 PH: 1-800-655-1777 Fax: [phone] FDA Reg. No. 1223133

CONTACT: Victor L. Ratkus, D.D.S.

DATE PREPARED: August 30, 1999

TRADE OR PROPRIETARY NAME: Oxy Glide™

CLASSIFICATION NAME: Root Canal Cleanser / Lubricant

PREDICATE DEVICE: RC-PREP Pre-1976 Device

DEVICE DESCRIPTION: Oxy Glide™ allows for cleansing action that facilitates easy removal of vital pulp tissue and necrotic pulp tissue from the root canal. It is designed to be used with endodontic irrigation with sodium hypochlorite solutions. Oxygen bubbling occurs through the release of oxygen from the urea peroxide. This action allows for the pulp tissue, dentinal shavings, and debris to float out.

The physical properties of Oxy Glide™ and the predicate device are similar, i. e., viscosity, appearance, color, and odor.

The intended use of Oxy Glide™ and the predicate device are the same, i.e., the cleansing and preparation of the root canal.

INTENDED USE: Oxy Glide™ is used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy.

TECHNOLOGICAL CHARACTERISTICS: The active ingredient in Oxy Glide™ and other components have been used in predicate medical devices and/or have been found safe for dental use.

We believe that, due to the long established safe and efficacious use of the predicate device in the same intended use, the same active ingredient, the short duration of contact within the oral cavity. and the decomposition and thorough removal of the product from the canal space, the use of Oxy Glide™ does not require additional biocompatibility testing and that Oxy Glide™ is safe for the intended uses.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping profiles of human faces, which are connected to three curved shapes resembling hands or supporting elements.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 9 1999

Victor L. Ratkus, D.D.S. President Super Glide, Inc. 227 Colchester Avenue Burlington, Vermont 05401

K992919 Re :

> Oxy Glide™ Root Canal Cleanser and Trade Name: Lubricant Unclassified Regulatory Class: Product Code: KJJ August 30, 1999 Dated: Received: August 30, 1999

Dear Dr. Ratkus:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any

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Page 2 - Dr. Ratkus

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic 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 the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 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/dsmamain.html".

Sincerely yours,

Timothy R. Wutkowski

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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## PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT (AS REQUIRED BY 21 CFR, 801.109)

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ___V

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Susan Remme

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number .