GC TION GINGIVAL PROTECTOR

K043301 · GC America, Inc. · EIE · Jan 25, 2005 · Dental

Device Facts

• Record ID: K043301
• Device Name: GC TION GINGIVAL PROTECTOR
• Applicant: GC America, Inc.
• Product Code: EIE · Dental
• Decision Date: Jan 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This product is light-cured composite resin indicated to protect soft tissue during in-office bleaching.

Device Story

GC TiON Gingival Protector is a light-cured composite resin material; applied by dental professionals to gingival tissue prior to in-office bleaching procedures; acts as a physical barrier to prevent contact between bleaching agents and soft tissue; cured via dental curing light; removed by clinician after bleaching procedure; benefits patient by reducing risk of chemical irritation or burns to gingiva during whitening treatments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured composite resin; applied as a paste/gel; polymerized via dental curing light; biocompatible material intended for temporary mucosal contact.

Indications for Use

Indicated for protection of soft tissue during in-office dental 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2005

Mr. Terry L. Joritz Director, Regulatory Affairs & Quality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

Re: K043301

Trade/Device Name: GC TiON GINGIVAL PROTECTOR Regulation Number: 872.6300 Regulation Name: Rubber Dam and Accessories Regulatory Class: I Product Code: EIE Dated: November 29, 2004 Received: November 6, 2004

Dear Mr. Joritz:

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 practive, 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 - Mr. Joritz

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DX 3 issualled of the vour device complies with other requirements mean that it 27 mas made a determind regulations administered by other Federal agencies. of the Act of ally I edelar statues and reguirements, including, but not limited to: registration 1 ou must colliply with an the Fice o req 21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), labolity systems (QS) regulation (21 CFR Part 820); and if requirements us set form in the quadisation 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) This letter will anow you to begal mading of substantial equivalence of your device to a premarket notification. The PDF 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), If you desire specific advice for your at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Parl 807.97). You may obtain other general information on your responsibilities under the Act from the may other of Small Manufacturers, International and Consumer Assistance at its toll-free Drimber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Chiu Liu, Ph.D.

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

510(k) Number (if known): _

Ko 43301

GC TiON GINGIVAL PROTECTOR Device Name:

Indications for Use:

This product is light-cured composite resin indicated to protect soft tissue during in-office bleaching.

Prescription Use (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Smer Ramos

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

210(k) Number:

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