510(k) K080631

CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER by Oral Health Technologies, LLC — Product Code EFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2008
Date Received
March 5, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Denture, Over The Counter
Device Class
Class I
Regulation Number
872.3520
Review Panel
DE
Submission Type