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510(k) K770872

IMPRESSION MATERIAL, ALGINATE by Espe GmbH (Us) — Product Code ELN

K770872 is an FDA 510(k) premarket notification submitted by Espe GmbH (Us) for the device "IMPRESSION MATERIAL, ALGINATE". The FDA issued a decision of Substantially Equivalent on June 1, 1977. The device falls under product code ELN (Teeth, Preformed Gold Denture), a Class I device regulated under 21 CFR 872.3580. Espe GmbH (Us) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1977
Date Received
May 13, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Teeth, Preformed Gold Denture
Device Class
Class I
Regulation Number
872.3580
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)

FDA data resources