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510(k) K991923

SOOTHE-N-SEAL CANKER SORE RELIEF by Closure Medical Corp. — Product Code MZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1999
Date Received
June 7, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Closure Medical Corp.

  • DEN090005 — PRINEO SKIN CLOSURE SYSTEM (April 30, 2010)
  • K002338 — LIQUIDERM LIQUID ADHESIVE BANDAGE (January 29, 2001)
  • K980159 — OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 (April 9, 1998)

Other clearances for product code MZW

  • K073209 — MAXCEM 2 (January 29, 2008)