GC ORAL MOISTURIZING GEL

K101346 · GC America, Inc. · LFD · Jan 27, 2011 · DE

Device Facts

• Record ID: K101346
• Device Name: GC ORAL MOISTURIZING GEL
• Applicant: GC America, Inc.
• Product Code: LFD · DE
• Decision Date: Jan 27, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

RX: GC Oral Moisturizing Gel is designed to provide comfort for individuals suffering from dry mouth. It is recommended to be used for people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth. OTC: GC Oral Moisturizing Gel is indicated for the relief of dry mouth symptoms, to provide a protective coating inside the mouth.

Device Story

GC Oral Moisturizing Gel is a topical oral agent formulated with polyglycerol (diglycerol) to moisturize, lubricate, and refresh the oral cavity. It functions as an artificial saliva substitute to provide comfort for patients suffering from dry mouth (xerostomia). The gel is applied intraorally to provide a protective coating, which helps alleviate discomfort and may assist in controlling bad breath. It is available in multiple flavors and is sugar-free and alcohol-free. The device is intended for both prescription and over-the-counter use by patients experiencing difficulties in eating or speaking due to dry mouth symptoms.

Clinical Evidence

Bench testing only. Performance specifications compared consistency (mm) and pH against predicate devices. A moisture desorption assay was conducted at 37°C and 20% humidity over 2 hours, showing a moisture desorption degree of 6.9% for the subject device compared to 10.1% for the predicate.

Technological Characteristics

Topical gel containing polyglycerol (60%), water (36%), sodium carboxymethylcellulose (2.5%), carrageenan (1.5%), sodium citrate, flavor, and ethyl p-hydroxybenzoate. Functions as a wetting/moisturizing agent. Non-electronic, non-sterile, standalone product.

Indications for Use

Indicated for individuals suffering from dry mouth, including those experiencing difficulty eating or speaking, to provide relief from symptoms and a protective oral coating.

Predicate Devices

• BioXtra Moisturizing Gel (K072306)
• Oral Balance Liquid/Gel (K061331)

Reference Devices

• GC MI Paste Plus (K070854)

Submission Summary (Full Text)

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K101346

CC

GC AMERICA INC 3737 WEST 127TH STREET AL SIP III INOIS 60803 TEL [phone] FAX [phone]

JAN 2 7 2011

### Section 6 - 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

- 1. Submitter Information: GC AMERICA INC.
3737 W. 127" Street Alsip, IL 60803
Contact Person: Mark Heiss, D.D.S. [phone] Phone: [phone] Fax:

May 7, 2010 Date Prepared:

- 2. Device Name: GC Oral Moisturizing Gel Proprietary Name: Saliva, Artificial Classification Name: Device Classification: Unclassified Produce Code: LFD
- Predicate Devices: 3.

| Company | Device | K Number |
|--------------------------|-----------------------|----------|
| BioXtra Moisturizing Gel | Bio-X Healthcare S.A. | K072306 |
| Oral Balance Liquid/Gel | Lacled, inc. | K061331 |

### Description of Device: 4.

GC Oral Moisturizing Gel contains polyglycerol (diglycerol) which, with other ingredients in the product, temporarily substitute the feel of natural saliva to moisturize, lubricate, and refresh the mouth. GC Oral Moisturizing Gel comes in five flavors: fruit salad, lemon, mint, orange and raspberry. GC Oral Moisturizing Gel is sugar free and alcohol free.

GC Oral Moisturizing Gel is substantially equivalent to BioXtra Moisturizing Gel and Oral Balance Liquid/Gel in its intended use. Both devices are artificial saliva agent designed for relief from dry mouth symptoms.

GC Oral Moisturizing Gel is designed to provide comfort for people suffering from dry mouth. It is recommended to be used for people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.

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#### ડ. Indications for Use:

RX:

GC Oral Moisturizing Gel is designed to provide comfort for individuals suffering from dry mouth. It is recommended to be used for people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.

OTC:

GC Oral Moisturizing Gel is indicated for the relief of dry mouth symptoms, to provide a protective coating inside the mouth, and help to control bad breath.

### 6. Technological characteristics:

GC Oral Moisturizing Gel contains polyglycerol (diglycerol) which, with other ingredients in the product, temporarily substitute the feel of natural saliva to moisturize, lubricate, and refresh the mouth.

This mode of action of the applicant devices is substantially equivalent to that of the predicate devices, BioXtra Moisturizing Gel and Oral Balance Liquid/Gel.

- 7. Summary of Physical tests:
Summary of Performance Specification

| | Consistency (mm) | pH |
|--------------------------|------------------|-----|
| GC Oral Moisturizing Gel | 32.5 | 7.2 |
| BioXtra Moisturizing Gel | 26.5 | 5.4 |
| Oral Balance Gel | 28.0 | 5.6 |

According to GC Corporation R & D test methods.

## Moisture Desorption Assay

0.4g of products were placed on a weighing dish and weighed followed by incubation under the condition of humidity of 20% and a temperature of 37 degrees Celsius for 2 hours. A value obtained by dividing the weight change by the initial weight in terms of percentage was designated as moisture desorption degree. The results obtained are shown below.

GC Dry Mouth Gel: 6.9% Biotene Oral Balance: 10.1%

### Description of Safety and Substantial Equivalence: 8.

The applicant device is substantially equivalent to the predicate devices in its intended use. Both devices are artificial saliva agent designed for relief from dry mouth symptoms.

All of the chemical components that constitute GC Oral Moisturizing Gel are previously used in the predicate devices which are legally marketed for the same indications and the same type of tissue contact. We believe that this fact well supports the compatibility of GC Oral Moisturizing Gel, and the safety of the applicant device is substantially equivalent to the predicate devices.

GC Oral Moisturizing gel is a wetting/moisturizing device.

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# Section 9 - Specifications and Substantial Equivalence Comparison

# Specifications and Substantial Equivalence Comparison

# 1. Device description and Intended Use

GC Oral Moisturizing Gel is designed to provide comfort for people suffering from dry mouth. It is recommended to be used for people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry morth,

The applicant device, GC Oral Moisturizing Gel, is substantially equivalent to BioXtra Moisturizing Gel and Oral Balance Liquid/Gel in its intended use. Both devices are artificial saliva agent designed for relief from dry mouth symptoms.

# 2. Components and Mode of Action

GC Oral Moisturizing Gel contains polyglycerol) which, with other ingredients in the product, temporarily substitute the feel of natural saliva to moisturize, lubricate, and refresh the mouth.

This mode of action of the applicant devices is substantially equivalent to that of the predicate devices, BioXtra Moisturizing Gel and Oral Balance Liquid/Gel.

All of the chemical components that constitute GC Oral Moisturizing Gel are:

# Chemical Formulation

| Component | Weight % | Predicate devices in prior use |
|-------------------------------|----------|--------------------------------|
| Polyglycerol (Diglycerol) | 60 | |
| Pure Water | 36 | GC MI Paste Plus (K070854) |
| Sodium carboxymethylcellulose | 2.5 | GC MI Paste Plus (K070854) |
| Carrageenan* | 1.5 | |
| Sodium Citrate | <0.5 | |
| Flavour | <0.5 | |
| Ethyl p-hydroxybenzoate | <0.1 | GC MI Paste Plus (K070854) |

GC Oral Molsturizing Gel

*Carrageenan is a thickening agent, CAS# 9000-07-1

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dr. Mark Heiss Director, Academic & Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

JAN 2 7 2011 -

Re: K101346 Trade/Device Name: GC Oral Moisturizing Gel Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LFD Dated: December 8, 2010 Received: December 9, 2010

Dear Dr. Heiss:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Dr. Heiss

Enclosure

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRI1's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hr for

Anthony D. Watson, B.S., M.S., M.B.A. 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 5 - Indications for Use Statement

## Indications for Use

510(k) Number (if known):

Device Name: GC Oral Moisturizing Gel

Indications for Use:

RX:

GC Oral Moisturizing Gel is designed to provide comfort for individuals suffering from dry mouth. It is recommended to be used for people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.

OTC:

GC Oral Moisturizing Gel is indicated for the relief of dry mouth symptoms, to provide a protective coating inside the mouth.

Prescription Use X AND/OR Over-The-Counter Use X
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: R101346

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