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510(k) K013375

BELLEGLASS HP OPAQUE 2 by Kerr Dental Materials Center — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2001
Date Received
October 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

Other clearances by Kerr Dental Materials Center

  • K050984 — BIOPLANT (August 11, 2005)
  • K031444 — OPTIBOND FL (July 2, 2003)
  • K030646 — BELLEGLASS POINT 4 (May 6, 2003)
  • K020303 — XR PRIMER 2 (April 19, 2002)
  • K020178 — BELLEGLASS HP MODELING GEL (March 15, 2002)
  • K014027 — OPTIBOND SOLO PLUS 4 (February 22, 2002)
  • K020092 — TEMPHASE (February 22, 2002)
  • K013325 — POINT 4 FLOWABLE 2 (October 23, 2001)
  • K011908 — OPTIBOND SOLO PLUS 3 (September 6, 2001)
  • K000357 — EZ CONNECT RESIN (April 28, 2000)

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