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510(k) K012849

GLASS POST by J. Morita USA, Inc. — Product Code ELR

K012849 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "GLASS POST". The FDA issued a decision of Substantially Equivalent on March 27, 2002. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. J. Morita USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2002
Date Received
August 3, 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 J. Morita USA, Inc.

  • K213477 — Root ZX3 (August 3, 2022)
  • K201378 — 3D Accuitomo 150N (February 18, 2021)
  • K190509 — Lubrina 2 (March 4, 2020)
  • K173920 — LS OIL (October 11, 2018)
  • K171012 — Veraview X800 (December 19, 2017)
  • K170275 — Tri Auto ZX2 (September 11, 2017)
  • K120377 — ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A (July 25, 2012)
  • K112665 — TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE (May 4, 2012)
  • K103697 — TORQTECH (January 20, 2012)
  • K090925 — MULTIPLE (APEX LOCATOR), MODEL RCM-7 (November 23, 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)
  • 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