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510(k) K212475

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) by Prevest Denpro Limited — Product Code EJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2022
Date Received
August 6, 2021
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 Prevest Denpro Limited

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  • K212563 — CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ul (May 23, 2022)
  • K200555 — Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superio (May 13, 2021)

Other clearances for product code EJK

  • K253248 — Bright Cavity Liner (January 13, 2026)
  • K230270 — 3M™ VitCal Liner/Base (February 6, 2023)
  • K201799 — CleaniCal (February 12, 2021)
  • 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)
  • K141047 — LC CALCIUMHYDROXIDE LINER (April 14, 2015)
  • K134022 — BASE IT (June 11, 2014)