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510(k) K061395

CALSET COMPOSITE HEATER by Addent, Inc. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2006
Date Received
May 19, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activator, Ultraviolet, For Polymerization
Device Class
Class II
Regulation Number
872.6070
Review Panel
DE
Submission Type

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  • K062961 — MICROLUX TRANSILLUMINATOR (February 8, 2007)
  • K041614 — MICROLUX DL (April 4, 2005)

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