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510(k) K960364

CU-200 LIGHT CURE UNIT by Rolence Enterprise Co. , Ltd. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1996
Date Received
January 25, 1996
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

Other clearances by Rolence Enterprise Co. , Ltd.

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  • K991865 — Q-LITE 75 LIGHT CURE UNIT (July 20, 1999)
  • K991863 — CUTE-LITE I LIGHT CURE UNIT (July 19, 1999)
  • K980792 — CU-100A LIGHT CURE UNIT (May 15, 1998)
  • K980793 — Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT (May 15, 1998)
  • K960351 — Q-LUX LIGHT CURE UNIT (April 15, 1996)
  • K953628 — PROPHY ANGLE (September 29, 1995)
  • K952423 — CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676 (June 22, 1995)
  • K942199 — CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 (June 2, 1994)
  • K942198 — CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 (May 27, 1994)

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