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510(k) K011908

OPTIBOND SOLO PLUS 3 by Kerr Dental Materials Center — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2001
Date Received
June 19, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sealant, Pit And Fissure, And Conditioner
Device Class
Class II
Regulation Number
872.3765
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)
  • 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)
  • K000357 — EZ CONNECT RESIN (April 28, 2000)

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  • K190339 — Helioseal F Plus (July 29, 2019)
  • K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCP (January 5, 2018)
  • K171330 — Nanova Sealant (September 8, 2017)
  • K162598 — HAPI Seal (May 23, 2017)
  • K161580 — Premier Sealant (October 18, 2016)
  • K141717 — PACSEAL PIT & FISSURE SEALANT (March 9, 2015)