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510(k) K801779

OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT by Oxy Dental Products, Inc. — Product Code EMB

K801779 is an FDA 510(k) premarket notification submitted by Oxy Dental Products, Inc. for the device "OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT". The FDA issued a decision of Substantially Equivalent on August 7, 1980. The device falls under product code EMB (Zinc Oxide Eugenol), a Class I device regulated under 21 CFR 872.3275. Oxy Dental Products, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1980
Date Received
July 28, 1980
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 Oxy Dental Products, Inc.

  • K801780 — OXY CUSTOM TRAY RESIN (August 7, 1980)

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)
  • K772315 — KWIKAP (January 3, 1978)

FDA data resources