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510(k) K862745

EUGENOL USP by E&D Dental Manufacturing Co. — Product Code EMB

K862745 is an FDA 510(k) premarket notification submitted by E&D Dental Manufacturing Co. for the device "EUGENOL USP". The FDA issued a decision of Substantially Equivalent on July 31, 1986. The device falls under product code EMB (Zinc Oxide Eugenol), a Class I device regulated under 21 CFR 872.3275. E&D Dental Manufacturing Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1986
Date Received
July 21, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Zinc Oxide Eugenol
Device Class
Class I
Regulation Number
872.3275
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)
  • K873738 — ACRYLIC BASE DENTURE MATERIALS (November 20, 1987)
  • K871639 — DENTAL DIAMOND BURS (May 18, 1987)
  • K864922 — DENTAL HANDPIECES AND ATTACHMENT (February 19, 1987)

Other clearances for product code EMB

  • K161630 — Provicol QM Plus (September 15, 2016)
  • K120695 — DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT (June 12, 2012)
  • K110759 — TEMPOCEM (June 10, 2011)
  • K073539 — PROVISA CEM (January 31, 2008)
  • K020158 — NON-EUGENOL TEMPORARY CEMENT (March 7, 2002)
  • K941066 — DENTAL 911 (May 24, 1995)
  • K861681 — DENTIMEDIC DENTAL EMERGENCY KIT (September 23, 1986)
  • K821581 — DEN TEMP (June 14, 1982)
  • K801779 — OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT (August 7, 1980)
  • K772315 — KWIKAP (January 3, 1978)

FDA data resources