Search Results
Found 1 results
510(k) Data Aggregation
K Number
K031809Device Name
PERIO PROTECT TRAY
Manufacturer
Date Cleared
2004-01-23
(225 days)
Product Code
Regulation Number
872.6870Why did this record match?
Product Code :
KMT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Perio Protect Tray is intended to be used to place solutions of the clinician's choice into gingival crevices or periodontal pockets. The design of the Perio Protect Tray permits placement of solutions deeper into the crevice/pocket than is possible with traditional fluoride trays.
The choice of solution, the frequency of use, and the time the tray is to be in place are a part of the practice of dentistry, and are to be determined by the clinician.
Device Description
The Perio Protect Tray is a custom fit tray made from impressions of the patents mouth taken by a licensed dentist. The patient impressions are then sent to a specialized dental laboratory which makes a custom fit tray for the individual patient.
Ask a Question
Ask a specific question about this device
Page 1 of 1