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510(k) K001050

CALCIJECT by Centrix, Inc. — Product Code EJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2000
Date Received
March 31, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Liner, Cavity, Calcium Hydroxide
Device Class
Class II
Regulation Number
872.3250
Review Panel
DE
Submission Type

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  • K143292 — TheraCal DC (August 4, 2015)
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