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510(k) K904096

PHOTAC-BOND by Espe GmbH (Us) — Product Code EJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1990
Date Received
September 6, 1990
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 Espe GmbH (Us)

  • K925027 — PHOTAC-FIL APLICAP (June 18, 1993)
  • K915005 — PHOTAC-BOND APLICAP, MODIFICATION (January 14, 1992)
  • K913966 — SONO(R) -CEM (January 14, 1992)
  • K913857 — ROCATEC(R) -PLUS (December 16, 1991)
  • K913965 — ESPE(R) -SIL (December 4, 1991)
  • K905604 — VISIO-GEM ART-SYSTEM (March 29, 1991)
  • K904097 — PHOTAC-BOND APLICAP (November 9, 1990)
  • K904289 — PERTAC UNIVERSAL BOND (November 1, 1990)
  • K900510 — PERTAC-HYBRID (August 9, 1990)
  • K900558 — PERTAC BOND (April 10, 1990)

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  • 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)