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510(k) K020091

OPTILUX 501 by Kerr Corporation (Danbury) — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2002
Date Received
January 10, 2002
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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  • K940513 — OPTIBOND (April 15, 1994)
  • K935535 — TYTIN (March 11, 1994)
  • 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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