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510(k) K121769

DENTOCORE / DENTOCORE BODY by Itena Clinical — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2013
Date Received
June 15, 2012
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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  • K121804 — PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM (April 19, 2013)
  • K122522 — DENTOETCH QUICKBOND BOND ACTIVATOR (March 19, 2013)

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