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510(k) K861681

DENTIMEDIC DENTAL EMERGENCY KIT by Dentimedic — Product Code EMB

K861681 is an FDA 510(k) premarket notification submitted by Dentimedic for the device "DENTIMEDIC DENTAL EMERGENCY KIT". The FDA issued a decision of Substantially Equivalent on September 23, 1986. The device falls under product code EMB (Zinc Oxide Eugenol), a Class I device regulated under 21 CFR 872.3275.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1986
Date Received
May 1, 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 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)
  • K862745 — EUGENOL USP (July 31, 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