GILB-2, GLASS IONOMER PROTECTIVE COATING


Device Classification Name

cement, dental

510(k) Number K073395
Device Name GILB-2, GLASS IONOMER PROTECTIVE COATING
Applicant
3M ESPE DENTAL PRODUCTS
3m center; bldg 260-2a-11
st. paul, 
MN 
55144 -1000

Applicant Contact karen o’malley
Correspondent
3M ESPE DENTAL PRODUCTS
3m center; bldg 260-2a-11
st. paul, 
MN 
55144 -1000

Correspodent Contact karen o’malley
Regulation Number 872.3275
Classification Product Code
EMA  
Subsequent Product Codes
EBC   EJK   LBH  
Date Received 12/03/2007
Decision Date 01/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes