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510(k) K020092

TEMPHASE by Kerr Dental Materials Center — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2002
Date Received
January 10, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
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)
  • 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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