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510(k) K873739

ACRYLIC IMPRESSION TRAY MATERIALS by E&D Dental Manufacturing Co. — Product Code EBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1988
Date Received
September 15, 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 E&D Dental Manufacturing Co.

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  • K873738 — ACRYLIC BASE DENTURE MATERIALS (November 20, 1987)
  • K871639 — DENTAL DIAMOND BURS (May 18, 1987)
  • K864922 — DENTAL HANDPIECES AND ATTACHMENT (February 19, 1987)
  • K862745 — EUGENOL USP (July 31, 1986)

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  • 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)