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510(k) K930487

PALATRAY LC MINT by Heraeus Kulzer, Inc. — Product Code EBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1993
Date Received
January 29, 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

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Other clearances for product code EBH

  • K933745 — PERMAGEN UNIVERSAL BONDING RESIN (January 26, 1994)
  • 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)