CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER


Device Classification Name

cleanser, denture, over the counter

510(k) Number K080631
Device Name CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER
Applicant
ORAL HEALTH TECHNOLOGIES, LLC
1062 allegheny drive
danville, 
CA 
94526

Applicant Contact robert e tricca
Correspondent
ORAL HEALTH TECHNOLOGIES, LLC
1062 allegheny drive
danville, 
CA 
94526

Correspodent Contact robert e tricca
Regulation Number 872.3520
Classification Product Code
EFT  
Date Received 03/05/2008
Decision Date 05/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No