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510(k) K030646

BELLEGLASS POINT 4 by Kerr Dental Materials Center — Product Code EBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2003
Date Received
February 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Filling Material, Resin
Device Class
Class II
Regulation Number
872.3310
Review Panel
DE
Submission Type

Other clearances by Kerr Dental Materials Center

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  • K020178 — BELLEGLASS HP MODELING GEL (March 15, 2002)
  • K014027 — OPTIBOND SOLO PLUS 4 (February 22, 2002)
  • K020092 — TEMPHASE (February 22, 2002)
  • K013375 — BELLEGLASS HP OPAQUE 2 (October 29, 2001)
  • 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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