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510(k) K121804

PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM by Itena Clinical — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2013
Date Received
June 19, 2012
Clearance Type
Abbreviated
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 Itena Clinical

  • K170207 — Obturys (July 31, 2017)
  • K162960 — TotalC-Ram (March 14, 2017)
  • K122551 — PROVITEMP (June 14, 2013)
  • K122521 — PREVENT SEAL (June 11, 2013)
  • K122549 — DENTO TEMP (April 26, 2013)
  • K122522 — DENTOETCH QUICKBOND BOND ACTIVATOR (March 19, 2013)
  • K121769 — DENTOCORE / DENTOCORE BODY (March 5, 2013)

Other clearances for product code EMA

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  • 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)