Search Results
Found 1 results
510(k) Data Aggregation
K Number
K041680Device Name
ORAJEL ADVANCED TOOTH DESENSITIZERManufacturer
Date Cleared
2004-11-10
(142 days)
Product Code
Regulation Number
872.3200Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
DEL PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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
AI/ML Overview
This is a 510(k) premarket notification for the Orajel Advanced Tooth Desensitizer, a resin tooth bonding agent. This document does not describe the acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information from the provided text.
Ask a Question
Ask a specific question about this device
Page 1 of 1