CASRRASYN ORAL WOUND DRESSING

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION February 25, 2025 Dennis R. Sparkman, Ph.D. Regulatory Affairs Carrington Laboratories, Incorporated P.O. Box 168128 Irving, Texas 75016 Re: K953423 Trade/Device Name: Casrrasyn Oral Wound Dressing Regulatory Class: Unclassified Product Code: OLR Dear Dr. Sparkman: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 11, 1995. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code OLR. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter, please contact Michael Adjodha, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices, 301-796-6276, Michael.Adjodha@fda.hhs.gov. Sincerely, **MICHAEL E. ADJODHA -S** Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} [LOGO] DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service OCT 11 1995 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dennis R. Sparkman Ph.D. Regulatory Affairs Carrington Laboratories, Incorporated P.O. Box 168128 Irving, Texas 75016 Re: K953423 Trade Name: Casrrasyn Oral Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: June 19, 1995 Received: June 20, 1995 Dear Dr. Sparkman: 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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. 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: 1. This device may not be labeled for use on third degree burns. 2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization. 3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin. 4. This device may not be labeled as a treatment or a cure 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). 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. {2} Page 2 - Dr. Sparkman 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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) 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 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 regulations. This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice regarding labeling for your device in accordance with 21 CFR Part 801, promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597. Timothy A. Ulatowski Timothy A. Ulatowski Acting Director Pilot Division Office of Device Evaluation Center for Devices and Radiological Health {3} # CARRINGTON K953483 K953483 OCT 11 1995 # 510 (k) SUMMARY Device Name: Classification Name: Dressings, wound and burns, hydrogel Common Name: Hydrogel Wound Dressings Proprietary Names: Carrasyn® Oral Wound Dressing Device Sponsor: Carrington Laboratories, Inc. 2001 Walnut Hill Lane Irving, TX 75038-4404 Registration No: 162544 Regulatory Classification: Unclassified. (Product code MGQ) Summary of Safety and Effectiveness: This 510 (k) Premarket Notification (951417) is the clarification of previously cleared indications for the labeling of Carrasyn® Oral Wound Dressing. Carrasyn® Oral Wound Dressing was originally marketed pursuant to 510 (k) Number K933741 and was reviewed by the Dental Section in the Division of General and Restorative Devices by Angela Blackwell. The 510 (k) notification described the product as follows: "PRODUCT DESCRIPTION: Carrasyn™ Oral Wound Dressing is a hydrogel in freeze-dried form used for the management of oral ulcers..." with labeling that recommended its use specifically for "canker sores (Aphthous ulcers)," the most common form of the idiopathic oral ulcers. Since the category of "oral ulcers" discussed in the original 510 (k) for oral wound dressing is broad and the labeling indication for "canker sores" is specific, we propose to clarify this product's uses as follows. We would like to amend the label indications for this oral wound dressing to include management of all types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa, including canker sores and traumatic ulcers, such as those caused by braces and ill-fitting dentures. CARRINGTON LABORATORIES, INC. • P.O. BOX 168128 • IRVING, TX 75016-8128 01 WALNUT HILL LN. • IRVING, TX 75038 • PHONE: 214/518-1300 • FAX: 214/518-1020