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510(k) K993545

TENAX WHITE POST by Coltene/Whaledent, Inc. — Product Code ELR

K993545 is an FDA 510(k) premarket notification submitted by Coltene/Whaledent, Inc. for the device "TENAX WHITE POST". The FDA issued a decision of Substantially Equivalent on April 14, 2000. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. Coltene/Whaledent, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2000
Date Received
October 19, 1999
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 Coltene/Whaledent, Inc.

  • K191385 — BRILLIANT COMPONEER (October 29, 2019)
  • K190597 — BRILLIANT EverGlow Flow (June 21, 2019)
  • K181500 — BRILLIANT Crios (August 15, 2018)
  • K160800 — DuoCem (November 16, 2016)
  • K152927 — BRILLIANT EVERGLOW (April 28, 2016)
  • K152243 — One Coat 7 Universal (December 9, 2015)
  • K150218 — Fill-Up! (June 23, 2015)
  • K130137 — BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER (August 23, 2013)
  • K121621 — SOLOCEM (January 8, 2013)
  • K112168 — COMPONEER (November 21, 2011)

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)
  • K003219 — HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST (October 25, 2000)

FDA data resources