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510(k) K992067

BELLEGLAZE by Kerr Dental Materials Center — Product Code EBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1999
Date Received
June 18, 1999
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

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  • K020178 — BELLEGLASS HP MODELING GEL (March 15, 2002)
  • K020092 — TEMPHASE (February 22, 2002)
  • K014027 — OPTIBOND SOLO PLUS 4 (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)

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