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510(k) K875228

PERMADYNE ADHESIVE by Espe GmbH (Us) — Product Code EBH

K875228 is an FDA 510(k) premarket notification submitted by Espe GmbH (Us) for the device "PERMADYNE ADHESIVE". The FDA issued a decision of Substantially Equivalent on March 9, 1988. The device falls under product code EBH (Material, Impression Tray, Resin), a Class I device regulated under 21 CFR 872.3670. Espe GmbH (Us) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1988
Date Received
December 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression Tray, Resin
Device Class
Class I
Regulation Number
872.3670
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)

Other clearances for product code EBH

  • K933745 — PERMAGEN UNIVERSAL BONDING RESIN (January 26, 1994)
  • K930487 — PALATRAY LC MINT (June 18, 1993)
  • K923979 — LC TRAY MATERIAL (November 17, 1992)
  • K923549 — PALADISC LC (September 29, 1992)
  • K912820 — POLYESTER RESIN HAND MOLDED TRAY (August 21, 1991)
  • K905058 — PALAVIT L (June 6, 1991)
  • K902350 — PALATRAY LC RESIN IMPRESSION TRAY MATERIAL (July 26, 1990)
  • K901782 — CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM (June 29, 1990)
  • K890712 — ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS (April 25, 1989)
  • K881838 — MODIFIED PERMAGUM ADHESIVE (July 27, 1988)

FDA data resources