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510(k) K202413

LC ResinCal PC by S&C Polymer Silicon- Und Composite Spezialitaten GmbH — Product Code EJK

K202413 is an FDA 510(k) premarket notification submitted by S&C Polymer Silicon- Und Composite Spezialitaten GmbH for the device "LC ResinCal PC". The FDA issued a decision of Substantially Equivalent on November 20, 2020. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. S&C Polymer Silicon- Und Composite Spezialitaten GmbH has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2020
Date Received
August 24, 2020
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 Spezialitaten GmbH

  • K222445 — LC ChromeFlow (March 6, 2023)

Other clearances for product code EJK

  • K253248 — Bright Cavity Liner (January 13, 2026)
  • K230270 — 3M™ VitCal Liner/Base (February 6, 2023)
  • K212475 — Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) (May 13, 2022)
  • K201799 — CleaniCal (February 12, 2021)
  • 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)

FDA data resources