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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

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

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  • K801779 — OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT (August 7, 1980)
  • K772315 — KWIKAP (January 3, 1978)