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510(k) K013802

FRC POSTEC by Ivoclar Vivadent, Inc. — Product Code ELR

K013802 is an FDA 510(k) premarket notification submitted by Ivoclar Vivadent, Inc. for the device "FRC POSTEC". The FDA issued a decision of Substantially Equivalent on May 1, 2002. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. Ivoclar Vivadent, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2002
Date Received
November 15, 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 Ivoclar Vivadent, Inc.

  • K261485 — Tetric plus Fill;Tetric plus Flow (July 1, 2026)
  • K253953 — IPS e.max Zirconia (March 10, 2026)
  • K252450 — Adhese 2 (March 5, 2026)
  • K233995 — Ivotion Base Print (February 23, 2024)
  • K210804 — Adhese Universal DC, Cention Primer (June 7, 2022)
  • K211916 — IPS e.max One (August 20, 2021)
  • K193193 — Telio CAD Abutment Solutions- extra systems (November 16, 2020)
  • K191453 — Cervitec F (February 11, 2020)
  • K191448 — Barrier Sleeves (October 8, 2019)
  • K191382 — IPS e.max CAD Abutment Solutions- extra systems (August 26, 2019)

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)
  • 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