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510(k) K020431

FIBIOCORE by Est. Anthogyr — Product Code ELR

K020431 is an FDA 510(k) premarket notification submitted by Est. Anthogyr for the device "FIBIOCORE". The FDA issued a decision of Substantially Equivalent on July 3, 2002. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. Est. Anthogyr has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2002
Date Received
February 8, 2002
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 by Est. Anthogyr

  • K070084 — MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL (March 8, 2007)
  • K060317 — ANTHOGYR CONTRA ANGLES AND HANDPIECES (April 28, 2006)

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)
  • 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