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510(k) K011154

ELIPAR FREELIGHT by Espe Dental AG — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2001
Date Received
April 16, 2001
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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  • K000591 — DIMENSION PENTA H, DIMENSION PENTA H QUICK (March 30, 2000)
  • K000588 — DIMENSION GARANT L, DIMENSION GARANT L QUICK (March 30, 2000)
  • K994192 — IMPREGUM PENTA M MONOSOFT (January 28, 2000)
  • K994193 — IMPREGUM PENTA DUOSOFT (January 28, 2000)
  • K994190 — IMPREGUM GARANT L DUOSOFT (January 27, 2000)

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