ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH


Device Classification Name

varnish, cavity

510(k) Number K080228
Device Name ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
Applicant
NOVAMIN TECHNOLOGY, INC.
13859 progress blvd.,#600
alachua, 
FL 
32615

Applicant Contact robert g rothfritz
Correspondent
NOVAMIN TECHNOLOGY, INC.
13859 progress blvd.,#600
alachua, 
FL 
32615

Correspodent Contact robert g rothfritz
Regulation Number 872.3260
Classification Product Code
LBH  
Date Received 01/30/2008
Decision Date 03/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No