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510(k) K020158

NON-EUGENOL TEMPORARY CEMENT by J. Morita USA, Inc. — Product Code EMB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2002
Date Received
January 17, 2002
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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  • K941066 — DENTAL 911 (May 24, 1995)
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  • 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)