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510(k) K122549

DENTO TEMP by Itena Clinical — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2013
Date Received
August 21, 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

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  • K162960 — TotalC-Ram (March 14, 2017)
  • K122551 — PROVITEMP (June 14, 2013)
  • K122521 — PREVENT SEAL (June 11, 2013)
  • K121804 — PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM (April 19, 2013)
  • K122522 — DENTOETCH QUICKBOND BOND ACTIVATOR (March 19, 2013)
  • K121769 — DENTOCORE / DENTOCORE BODY (March 5, 2013)

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