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510(k) K030776

MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL by Discus Dental, Inc. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2003
Date Received
March 11, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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  • K033785 — PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE (June 18, 2004)

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