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510(k) K162662

GingiDent Gingival Retraction Paste by Pac-Dent International, Inc. — Product Code MVL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2017
Date Received
September 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Pac-Dent International, Inc.

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  • K151150 — Elements (July 28, 2015)
  • K141717 — PACSEAL PIT & FISSURE SEALANT (March 9, 2015)
  • K141422 — PROFLUORO FLUORIDE VARNISH (September 30, 2014)
  • K130672 — OPTIFLOW II FLOWABLE COMPOSITE, LC (August 13, 2013)

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