Home / 510(k) Clearances / K110759

510(k) K110759

TEMPOCEM by Dmg USA, Inc. — Product Code EMB

K110759 is an FDA 510(k) premarket notification submitted by Dmg USA, Inc. for the device "TEMPOCEM". The FDA issued a decision of Substantially Equivalent on June 10, 2011. The device falls under product code EMB (Zinc Oxide Eugenol), a Class I device regulated under 21 CFR 872.3275. Dmg USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2011
Date Received
March 18, 2011
Clearance Type
Abbreviated
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 Dmg USA, Inc.

  • K171772 — Ecosite Bulk Fill (January 31, 2018)
  • K160443 — TempoCem Clear (September 30, 2016)
  • K130580 — RETRACTION PASTE (February 25, 2014)
  • K102603 — SA FLOWABLE ADHESIVE (November 17, 2010)
  • K101710 — LUXATEMP ULTRA /STAR (September 28, 2010)
  • K100062 — INFILTRATION KIT (March 26, 2010)
  • K093338 — SELF ADHESIVE COMPOSITE LUTING CEMENT (February 12, 2010)
  • K093587 — DENTAL MERCURY (January 21, 2010)
  • K081493 — INFILTRATION KIT (September 18, 2008)
  • K080480 — NANOCOMPOSITE RESTORATIVE KIT (May 30, 2008)

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)
  • 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)
  • K772315 — KWIKAP (January 3, 1978)

FDA data resources