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510(k) K052271

RINSENDO by Air Techniques, Inc. — Product Code NYL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2006
Date Received
August 19, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Root Canal Irrigation
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

To clean the root canal prior to filling and used for root canal irrigation.

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