SOOTHE-N-SEAL CANKER SORE RELIEF


Device Classification Name

dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief

510(k) Number K991923
Device Name SOOTHE-N-SEAL CANKER SORE RELIEF
Applicant
CLOSURE MEDICAL CORP.
5250 greens dairy rd.
raleigh, 
NC 
27616

Applicant Contact w. thomas stephens
Correspondent
CLOSURE MEDICAL CORP.
5250 greens dairy rd.
raleigh, 
NC 
27616

Correspodent Contact w. thomas stephens
Regulation Number 872.3275
Classification Product Code
MZW  
Date Received 06/07/1999
Decision Date 09/02/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No