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510(k) K003219

HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST by Harald Nordin S.A — Product Code ELR

K003219 is an FDA 510(k) premarket notification submitted by Harald Nordin S.A for the device "HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST". The FDA issued a decision of Substantially Equivalent on October 25, 2000. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. Harald Nordin S.A has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2000
Date Received
October 16, 2000
Clearance Type
Special
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 by Harald Nordin S.A

  • K003221 — HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST (October 25, 2000)
  • K931396 — DENTAL SCREW POSTS (April 28, 1994)

Other clearances for product code ELR

  • K060075 — FIBER-METAL POST (March 30, 2006)
  • 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)
  • K993545 — TENAX WHITE POST (April 14, 2000)

FDA data resources