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510(k) K051545

L.E. DEMETRON II by Kerr Corporation (Danbury) — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2005
Date Received
June 10, 2005
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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  • K934690 — KERR OPTIBOND, MODIFICATION (December 30, 1993)
  • K923546 — OPTIBOND (September 29, 1992)
  • K915847 — AUTOMIX DENTAL AMALGAMATOR (March 2, 1992)
  • K904756 — MATRICS (March 15, 1991)

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