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510(k) K012354

SNOWPOST, SNOWLIGHT by Danville Materials, Inc. — Product Code ELR

K012354 is an FDA 510(k) premarket notification submitted by Danville Materials, Inc. for the device "SNOWPOST, SNOWLIGHT". The FDA issued a decision of Substantially Equivalent on October 10, 2001. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. Danville Materials, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2001
Date Received
July 25, 2001
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 Danville Materials, Inc.

  • K152349 — Star+ VPS Scannable Impression Material (November 23, 2015)
  • K151514 — Prestige (September 21, 2015)
  • K151088 — DMRC Bulk Fill (August 28, 2015)
  • K142886 — DMRC Self-Cure Bracket Adhesive One Step and Primer (March 18, 2015)
  • K142881 — DMRC Dual Cure Orthodontic Band Cement (February 13, 2015)
  • K121880 — DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID (September 25, 2012)
  • K111876 — Z BOND, PRELUDE ONE (September 21, 2011)
  • K110642 — SILJETR SYSTEM (May 27, 2011)
  • K102753 — TURBO TEMP 3 (February 4, 2011)
  • K092912 — STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW V (December 16, 2009)

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)
  • 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