ALOE THERAPY ORAL RINSE

K983182 · Carrington Laboratories, Inc. · OLR · Dec 10, 1998 · SU

Device Facts

• Record ID: K983182
• Device Name: ALOE THERAPY ORAL RINSE
• Applicant: Carrington Laboratories, Inc.
• Product Code: OLR · SU
• Decision Date: Dec 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Carrington Laboratories Caraloe Oral Rinse provides fast pain relief and is recommended for the conning of a lives of oral wounds, mouth sore injuries and ulcers of the oral mucosa, including canker son s and traumatic ulcers such as those caused by braces and ill-fitting dentures. Safe if swallowed

Device Story

Caraloe Oral Rinse is a topical oral solution used for the management of oral mucosal wounds and ulcers. It provides pain relief for conditions such as canker sores and traumatic injuries from dental appliances. The device is intended for over-the-counter use by patients. It functions as a protective or soothing agent for the oral mucosa. It is not indicated for third-degree burns, wound healing acceleration, or as a permanent dressing.

Indications for Use

Indicated for patients experiencing oral wounds, mouth sore injuries, and ulcers of the oral mucosa, including canker sores and traumatic ulcers resulting from braces or ill-fitting dentures. Safe for ingestion.

Regulatory Classification

Identification

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1998

Carrington Laboratories, Incorporated C/O Mr. E. J. Smith Consultant Smith Associates P.O. Box 4341 21114 Crofton, Maryland

K983182 Re : Caraloe Oral Rinse Trade Name: Regulatory Class: Unclassified Product Code: MGQ Dated: September 11, 1998 September 11, 1998 Received:

Dear Mr. Smith:

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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- This device may not be labeled for use on third degree 1. burns .
- This device may not be labeled as having any accelerating 2. effect on the rate of wound healing or epithelization.
- This device may not be labeled as a long-term, 3 . permanent, or no-change dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure 4 . for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

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Page 2 - Mr. Smith

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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 requlations affecting your device can be found in the Code of Federal Requlations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP requlation (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 the Federal Register. Please note: this response to your premarket notification submission does not affect any 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 requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely,

Patricia Cucenitto/tor

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

Device Name: Carrir gton Laboratories Caraloe Oral Rinse

Classification Panel

Indications for Use:

The Carrington Laboratories Caraloe Oral Rinse provides fast pain relief and is recommended for the conning of a lives of oral wounds, mouth sore injuries and ulcers of the oral mucosa, including canker son s and traumatic ulcers such as those caused by braces and ill-fitting dentures.

Safe if swallowed

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## Concurrence of CDRH, Office of Device Evaluation (ODE) Perscription Use or Over the Counter Use over (Division Sign-Off)

( Colleton of Dental, Infection Control.
and General Hospital, Infection Control. and General Hospital Infection
Food General Hospital Devices 510(k) Number

ver the Counter Use