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510(k) K020303

XR PRIMER 2 by Kerr Dental Materials Center — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2002
Date Received
January 29, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

Other clearances by Kerr Dental Materials Center

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  • K031444 — OPTIBOND FL (July 2, 2003)
  • K030646 — BELLEGLASS POINT 4 (May 6, 2003)
  • 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)
  • K000357 — EZ CONNECT RESIN (April 28, 2000)

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  • K240153 — Ceramic Etchant (HF-5 and HF-9) (October 2, 2024)