Cleared Traditional

K945370 - C-POST

K945370 is the FDA 510(k) clearance for C-POST by Bisco, Inc.. It is a Class 1 Dental device (product code ELR) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K945370 · Bisco, Inc. · Dental device
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Mar 1995
Decision
149d
Days
Class 1
Risk

K945370 is an FDA 510(k) clearance for the C-POST. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by Bisco, Inc. (Itasca, US). The FDA issued a Cleared decision on March 31, 1995 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3810 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Bisco, Inc. devices

Submission Details

510(k) Number K945370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1994
Decision Date March 31, 1995
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ELR Post, Root Canal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ELR Post, Root Canal

All 10
Devices cleared under the same product code (ELR) and FDA review panel - the closest regulatory comparables to K945370.
GLASS POST
K012849 · J. Morita USA, Inc. · Mar 2002
FIBREKOR POST SYSTEM
K983266 · Jeneric/Pentron, Inc. · Nov 1998
COSMOPOST
K972875 · Ivoclar North America, Inc. · Sep 1997
ENDO-CORE
K912720 · Metalor Dental USA Corp. · Aug 1991
FILPOST
K896928 · Ivoclar North America, Inc. · Mar 1990
AD POST
K884277 · J. Morita USA, Inc. · Dec 1988