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510(k) K772315

KWIKAP by Den-Mat Corp. — Product Code EMB

K772315 is an FDA 510(k) premarket notification submitted by Den-Mat Corp. for the device "KWIKAP". The FDA issued a decision of Substantially Equivalent on January 3, 1978. The device falls under product code EMB (Zinc Oxide Eugenol), a Class I device regulated under 21 CFR 872.3275. Den-Mat Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1978
Date Received
December 19, 1977
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 Den-Mat Corp.

  • K983106 — 1ST IMPRESSION (February 9, 1999)
  • K895731 — DEN-MAT CERINATE PORCELAIN (August 3, 1990)
  • K895269 — DEN-MAT LAMI-QUICK (February 22, 1990)
  • K881918 — LIGHT-CURED ZIONOMER CEMENT (July 15, 1988)
  • K875351 — DEN-MAT PORETCH (PORCELAIN ETCHANT) (March 18, 1988)
  • K872510 — DEN-MAT TENURE (August 24, 1987)
  • K870130 — DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM (February 19, 1987)
  • K864346 — REMBRANDT PORCELAIN TINTING KIT (January 7, 1987)
  • K862449 — DEN-MAT DENTIN LINK (July 22, 1986)
  • K860971 — DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) (March 25, 1986)

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)
  • 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)

FDA data resources