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510(k) K120695

DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT by Dentist IN A Box Pty., Ltd. — Product Code EMB

K120695 is an FDA 510(k) premarket notification submitted by Dentist IN A Box Pty., Ltd. for the device "DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT". The FDA issued a decision of Substantially Equivalent on June 12, 2012. 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
June 12, 2012
Date Received
March 7, 2012
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)
  • 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)
  • 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