Home / 510(k) Clearances / K040343

510(k) K040343

TEMP F by Novocol, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2004
Date Received
February 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Novocol, Inc.

  • K141994 — BULK FILL FLOWABLE COMPOSITE (November 14, 2014)
  • K130601 — BIOROOT RCS (October 17, 2013)
  • K120237 — BPA-FREE MICROHYBID COMPOSITE (December 11, 2012)
  • K120283 — DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT (July 31, 2012)
  • K120619 — ORTHODONTIC FLOWABLE BRACKET ADHESIVE (May 21, 2012)
  • K110484 — SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL (May 17, 2011)
  • K092501 — LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL (November 12, 2009)
  • K072150 — DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL (September 13, 2007)

Other clearances for product code EMA

  • K254063 — iCEM Universal Plus (December 19, 2025)
  • K252785 — TopCEM Vigor SA Self-Adhesive Resin Cement (December 12, 2025)
  • K252808 — GlasIonomer FX-LC (December 9, 2025)
  • K252165 — ZIRCONOMER P (October 28, 2025)
  • K250953 — EQUIA LC ONE (September 19, 2025)
  • K251775 — RODIN Cement (September 2, 2025)
  • K251470 — ResiCem EX (July 11, 2025)
  • K250156 — Choice 2 DC (July 11, 2025)
  • K250566 — EsCem RMGI (June 20, 2025)
  • K242366 — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abut (January 10, 2025)