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510(k) K020158

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

K020158 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "NON-EUGENOL TEMPORARY CEMENT". The FDA issued a decision of Substantially Equivalent on March 7, 2002. The device falls under product code EMB (Zinc Oxide Eugenol), a Class I device regulated under 21 CFR 872.3275. J. Morita USA, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by J. Morita USA, Inc.

  • K213477 — Root ZX3 (August 3, 2022)
  • K201378 — 3D Accuitomo 150N (February 18, 2021)
  • K190509 — Lubrina 2 (March 4, 2020)
  • K173920 — LS OIL (October 11, 2018)
  • K171012 — Veraview X800 (December 19, 2017)
  • K170275 — Tri Auto ZX2 (September 11, 2017)
  • K120377 — ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A (July 25, 2012)
  • K112665 — TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE (May 4, 2012)
  • K103697 — TORQTECH (January 20, 2012)
  • K090925 — MULTIPLE (APEX LOCATOR), MODEL RCM-7 (November 23, 2009)

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)
  • 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