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510(k) K073539

PROVISA CEM by Cavex Holland BV — Product Code EMB

K073539 is an FDA 510(k) premarket notification submitted by Cavex Holland BV for the device "PROVISA CEM". The FDA issued a decision of Substantially Equivalent on January 31, 2008. The device falls under product code EMB (Zinc Oxide Eugenol), a Class I device regulated under 21 CFR 872.3275. Cavex Holland BV has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2008
Date Received
December 17, 2007
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 Cavex Holland BV

  • K151535 — Cavex Cream Alginate (October 28, 2015)
  • K141092 — MARK3 (December 4, 2014)
  • K072245 — EMULATE ADVANCED (November 8, 2007)
  • K062400 — IMPRESSIX, COLORCHANGE ALGINATE (November 16, 2006)
  • K061267 — SIMULATE, COLOR CHANGE ALGINATE (July 10, 2006)
  • K052455 — IMPRESSIX (November 23, 2005)
  • K051207 — CAVEX ORTHOTRACE (June 21, 2005)
  • K042806 — QUADRANT UNIT-1-BOND (November 24, 2004)
  • K032116 — TULIP COLORSWITCH (September 30, 2003)
  • K023466 — TULIP ALGINATE IMPRESSION MATERIAL (December 13, 2002)

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)
  • 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