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510(k) K904289

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1990
Date Received
September 17, 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)
  • K913966 — SONO(R) -CEM (January 14, 1992)
  • K915005 — PHOTAC-BOND APLICAP, MODIFICATION (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)
  • K900510 — PERTAC-HYBRID (August 9, 1990)
  • K900558 — PERTAC BOND (April 10, 1990)

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