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510(k) K060075

FIBER-METAL POST by Foremost Dental, LLC — Product Code ELR

K060075 is an FDA 510(k) premarket notification submitted by Foremost Dental, LLC for the device "FIBER-METAL POST". The FDA issued a decision of Substantially Equivalent on March 30, 2006. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2006
Date Received
January 10, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Post, Root Canal
Device Class
Class I
Regulation Number
872.3810
Review Panel
DE
Submission Type

Other clearances for product code ELR

  • K042848 — FRC POSTEC PLUS (November 22, 2004)
  • K030820 — EVERSTICK POST (May 20, 2003)
  • K020431 — FIBIOCORE (July 3, 2002)
  • K012496 — CARBON POST (May 17, 2002)
  • K013802 — FRC POSTEC (May 1, 2002)
  • K012849 — GLASS POST (March 27, 2002)
  • K012354 — SNOWPOST, SNOWLIGHT (October 10, 2001)
  • K003221 — HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST (October 25, 2000)
  • K003219 — HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST (October 25, 2000)
  • K993545 — TENAX WHITE POST (April 14, 2000)

FDA data resources