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510(k) K821581

DEN TEMP by Majestic Drug Co., Inc. — Product Code EMB

K821581 is an FDA 510(k) premarket notification submitted by Majestic Drug Co., Inc. for the device "DEN TEMP". The FDA issued a decision of Substantially Equivalent on June 14, 1982. The device falls under product code EMB (Zinc Oxide Eugenol), a Class I device regulated under 21 CFR 872.3275. Majestic Drug Co., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
May 28, 1982
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 Majestic Drug Co., Inc.

  • K101771 — RELINE-IT MODEL RELINE-IT (September 20, 2010)
  • K964773 — DENTEMP ONE STEP (February 21, 1997)

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)
  • K801779 — OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT (August 7, 1980)
  • K772315 — KWIKAP (January 3, 1978)

FDA data resources