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510(k) K900558

PERTAC BOND by Espe GmbH (Us) — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1990
Date Received
February 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
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)
  • K904096 — PHOTAC-BOND (November 19, 1990)
  • K904097 — PHOTAC-BOND APLICAP (November 9, 1990)
  • K904289 — PERTAC UNIVERSAL BOND (November 1, 1990)
  • K900510 — PERTAC-HYBRID (August 9, 1990)

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