Home / 510(k) Clearances / K873738

510(k) K873738

ACRYLIC BASE DENTURE MATERIALS by E&D Dental Manufacturing Co. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1987
Date Received
September 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

Other clearances by E&D Dental Manufacturing Co.

  • K883698 — ZINC OXIDE EUGENOL TEMPORARY CEMENT (November 29, 1988)
  • K873739 — ACRYLIC IMPRESSION TRAY MATERIALS (March 7, 1988)
  • K871639 — DENTAL DIAMOND BURS (May 18, 1987)
  • K864922 — DENTAL HANDPIECES AND ATTACHMENT (February 19, 1987)
  • K862745 — EUGENOL USP (July 31, 1986)

Other clearances for product code EBI

  • K253365 — LuxCreo Flexible Partial Denture Resin (November 25, 2025)
  • K253681 — TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HA (November 21, 2025)
  • K253324 — UltraPrint-Dental Denture UV (November 20, 2025)
  • K252430 — Freeprint® denture flex (October 30, 2025)
  • K252035 — DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink p (September 17, 2025)
  • K250302 — Flexible Partial Resin (June 25, 2025)
  • K242897 — Partial Flex (June 3, 2025)
  • K250489 — FP3D (May 20, 2025)
  • K250617 — Apex Flex (April 29, 2025)
  • K243356 — Asiga DentaBASE (April 11, 2025)