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510(k) K897130

INTERFACE - CAVITY LINER by Scientific Pharmaceuticals, Inc. — Product Code EJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1990
Date Received
December 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Liner, Cavity, Calcium Hydroxide
Device Class
Class II
Regulation Number
872.3250
Review Panel
DE
Submission Type

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  • K191103 — Parkell Desensitizer Gel (November 22, 2019)
  • K180344 — TheraCal DC (April 5, 2018)
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  • K141047 — LC CALCIUMHYDROXIDE LINER (April 14, 2015)