510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991923Substantially Equivalent

Soothe-N-Seal Canker Sore Relief

Closure Medical Corp., Raleigh NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991923 is the FDA 510(k) clearance record for SOOTHE-N-SEAL CANKER SORE RELIEF, a class II device, cleared for Closure Medical Corp. on under FDA product code MZW (Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief). FDA records list 4 510(k) clearances for Closure Medical Corp., from to . As of , FDA records show no recalls naming K991923.

Clearance record

Decision date
Received
(87 days to decision)
Product code
MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Closure Medical Corp. 5250 Greens Dairy Rd., Raleigh NC
510(k) summary
Summary
Third party review
No

Clearances, product code MZW

Trailing 12 months

FDA records hold no clearances under product code MZW in the trailing twelve months.

FDA records show no clearances under product code MZW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MZW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260