Cleared Traditional

K060075 - FIBER-METAL POST

K060075 is an FDA 510(k) clearance for FIBER-METAL POST, manufactured by Foremost Dental, LLC. The device is a Class 1 Dental device with product code ELR cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K060075 · Foremost Dental, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
79d
Days
Class 1
Risk

K060075 is an FDA 510(k) clearance for the FIBER-METAL POST. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by Foremost Dental, LLC (Ayer, US). The FDA issued a Cleared decision on March 30, 2006 after a review of 79 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Foremost Dental, LLC devices

FDA 510(k) Submission Details - K060075

510(k) Number K060075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2006
Decision Date March 30, 2006
Days to Decision 79 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

ELR Device Classification - Class 1, General Controls

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 20
Devices cleared under the same product code (ELR) and FDA review panel - the closest regulatory comparables to K060075.
FRC POSTEC PLUS
K042848 · Ivoclar Vivadent, Inc. · Nov 2004
CARBON POST
K012496 · J. Morita USA, Inc. · May 2002
FRC POSTEC
K013802 · Ivoclar Vivadent, Inc. · May 2002
GLASS POST
K012849 · J. Morita USA, Inc. · Mar 2002
TENAX WHITE POST
K993545 · Coltene/Whaledent, Inc. · Apr 2000
PARAPOST FIBER WHITE
K000311 · Coltene/Whaledent, Inc. · Mar 2000