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510(k) K890712

ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS by Advantage Dental Products, Inc. — Product Code EBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1989
Date Received
February 13, 1989
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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  • 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)
  • K881838 — MODIFIED PERMAGUM ADHESIVE (July 27, 1988)
  • K875257 — IMPREGUM F ADHESIVE (March 9, 1988)