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510(k) K091792

REST ASSURED GENERATION II DENTAL PROTECTOR by Ranir Corporation — Product Code OBR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2009
Date Received
June 17, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Over-The-Counter
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

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