# K991923: Soothe-N-Seal Canker Sore Relief

- Pathway: 510(k) (Traditional)
- Applicant: Closure Medical Corp.
- Decided: Sep 2, 1999 after 87 days
- Product code: MZW (Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902078 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902078: Add'l Indication for Octyldent 2-Octyl Cranoacry., Crx Medical, Inc. (1990) Summary page 1.
- K980159: Octyldent (2-Octyl Cyanoacrylate), 02A01, Closure Medical Corp. (1998) Summary page 1.
- K933741: Carrasyn Oral Wound Dressing, Carrington Laboratories, Inc. (1994) Summary page 1.
- K964852: Radiacare Oral Wound Rinse, Carrington Laboratories, Inc. (1997) Summary page 1.

## Indications for use
SOOTHE-N-SEAL™ Canker Sore Relief creates a thin, protective barrier that provides relief of pain associated with canker sores, mouth sores, and traumatic ulcers, such as those caused by braces.

Source page: https://510kreport.com/device/K991923
Methodology: https://510kreport.com/methodology