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510(k) K040661

RADENT PROPHY PASTE by Pascal Co., Inc. — Product Code EJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2004
Date Received
March 12, 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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  • K101104 — REMIN PRO (October 21, 2010)
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  • K070854 — GC MI PASTE PLUS (April 12, 2007)
  • K062502 — OSSPRAY CLEANING COMPOUND (December 15, 2006)
  • K062166 — ENAMEL PRO (November 21, 2006)