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510(k) K933745

PERMAGEN UNIVERSAL BONDING RESIN by Bio-Systems Research — Product Code EBH

K933745 is an FDA 510(k) premarket notification submitted by Bio-Systems Research for the device "PERMAGEN UNIVERSAL BONDING RESIN". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code EBH (Material, Impression Tray, Resin), a Class I device regulated under 21 CFR 872.3670. Bio-Systems Research has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1994
Date Received
August 3, 1993
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 Bio-Systems Research

  • K962416 — DRYTIME FOR BLADDER CONTROL SILENT (July 22, 1996)

Other clearances for product code EBH

  • 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)
  • K875228 — PERMADYNE ADHESIVE (March 9, 1988)

FDA data resources