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510(k) K090457

ORALUBE by Pulpdent Corporation — Product Code ONK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2009
Date Received
February 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oral Lubricant
Device Class
Class I
Regulation Number
880.6375
Review Panel
DE
Submission Type

An oral lubricant to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; Placement of a rubber dam; And to prevent the lips from drying and cracking during dental procedures.

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