Cleared Traditional

K991923 - SOOTHE-N-SEAL CANKER SORE RELIEF (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K991923 · Closure Medical Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
87d
Days
Class 2
Risk

K991923 is an FDA 510(k) clearance for the SOOTHE-N-SEAL CANKER SORE RELIEF. Classified as Dental Cement W/out Zinc-oxide Eugenol As An Ulcer Covering For Pain Relief (product code MZW), Class II - Special Controls.

Submitted by Closure Medical Corp. (Raleigh, US). The FDA issued a Cleared decision on September 2, 1999 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Closure Medical Corp. devices

Submission Details

510(k) Number K991923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1999
Decision Date September 02, 1999
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MZW Dental Cement W/out Zinc-oxide Eugenol As An Ulcer Covering For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.