C-Post

FDA 510(k) K945370 · Bisco, Inc.

Substantially Equivalent

510(k) numberK945370

Submission

Device name
C-Post
Applicant
Bisco, Inc.
Itasca, IL, US
Received
November 2, 1994
Decision date
March 31, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
ELR – Post, Root Canal
Device class
Class I (low risk)
Regulation
21 CFR 872.3810
Specialty
Dental

Other 510(k)s with product code ELR

510(k)DeviceApplicantDecision
K060075Fiber-Metal PostELR · Traditional Foremost Dental, LLC03/30/2006SE
K042848FRC Postec PlusELR · Traditional Ivoclar Vivadent, Inc.11/22/2004SE
K030820Everstick PostELR · Traditional Stick Tech , Ltd.05/20/2003SE
K020431FibiocoreELR · Traditional Est. Anthogyr07/03/2002SE
K012496Carbon PostELR · Traditional J. Morita USA, Inc.05/17/2002SE
K013802FRC PostecELR · Traditional Ivoclar Vivadent, Inc.05/01/2002SE
K012849Glass PostELR · Traditional J. Morita USA, Inc.03/27/2002SE
K012354Snowpost, SnowlightELR · Traditional Danville Materials, Inc.10/10/2001SE
K003221Harald Nordin Glassix Glass Fiber Composite Dental PostELR · Special Harald Nordin S.A10/25/2000SE
K003219Harald Nordin Carbonite Carbon Fiber Composite Dental PostELR · Special Harald Nordin S.A10/25/2000SE

More from Harald Nordin S.A

510(k)DeviceDecision
K250156Choice 2 DCEMA · Traditional 07/11/2025SE
K242816QuantiumEBF · Traditional 12/17/2024SE
K192007TheraBase, TheraBase CaEMA · Traditional 03/17/2020SE
K182917FluoroCalLBH · Traditional 11/18/2019SE
K180344TheraCal DCEJK · Special 04/05/2018SE
K171147REVEAL BulkEBF · Traditional 08/04/2017SE
K162598HAPI SealEBC · Traditional 05/23/2017SE
K163171CeraCleanPME · Traditional 04/14/2017SE
K161051All-Bond Universal w/BAC (not finalized)KLE · Traditional 09/09/2016SE
K161256TheraCemEMA · Traditional 07/29/2016SE

Questions and answers

When was C-Post cleared by the FDA?

C-Post (K945370) received a 510(k) decision of Substantially Equivalent on March 31, 1995, 149 days after the submission was received.

What is the product code of K945370?

The FDA product code is ELR – Post, Root Canal, a Class I (low risk) device regulated under 21 CFR 872.3810.