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510(k) Data Aggregation
K Number
K041680Device Name
ORAJEL ADVANCED TOOTH DESENSITIZER
Manufacturer
DEL PHARMACEUTICALS, INC.
Date Cleared
2004-11-10
(142 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
DEL PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tooth Desensitizer Indications For Use:
Prescription Use (Part 21 CFR 801 Subpart D) . AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Device Description
Not Found
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