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510(k) K991863

CUTE-LITE I LIGHT CURE UNIT by Rolence Enterprise Co. , Ltd. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1999
Date Received
June 1, 1999
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.

  • K001719 — Q-LUX PLASMA 100 LIGHT CURE UNIT (October 10, 2000)
  • K991865 — Q-LITE 75 LIGHT CURE UNIT (July 20, 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)
  • K960364 — CU-200 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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