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510(k) K042048

GELATO PROPHYLAXIS PASTE by Deepak Products, Inc. — Product Code EJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2004
Date Received
July 30, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Polishing, Abrasive, Oral Cavity
Device Class
Class I
Regulation Number
872.6030
Review Panel
DE
Submission Type

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