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510(k) K141047

LC CALCIUMHYDROXIDE LINER by S&C Polymer Silicon- Und Composite Spezialitaeten — Product Code EJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2015
Date Received
April 23, 2014
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

Other clearances by S&C Polymer Silicon- Und Composite Spezialitaeten

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  • K130125 — MTA CEMENTS (July 24, 2013)

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  • K202413 — LC ResinCal PC (November 20, 2020)
  • K191103 — Parkell Desensitizer Gel (November 22, 2019)
  • K180344 — TheraCal DC (April 5, 2018)
  • K143292 — TheraCal DC (August 4, 2015)
  • K150559 — Life Fast Set, Life Regular Set (June 19, 2015)
  • K134022 — BASE IT (June 11, 2014)