Cleared Special

K003219 - HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST

K003219 is an FDA 510(k) clearance for HARALD NORDIN CARBONITE CARBON FIBER CO..., manufactured by Harald Nordin S.A. The device is a Class 1 Dental device with product code ELR cleared through the Special 510(k) pathway after a 9-day FDA review.

K003219 · Harald Nordin S.A · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
9d
Days
Class 1
Risk

K003219 is an FDA 510(k) clearance for the HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by Harald Nordin S.A (Concord, US). The FDA issued a Cleared decision on October 25, 2000 after a review of 9 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K003219

510(k) Number K003219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2000
Decision Date October 25, 2000
Days to Decision 9 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 128d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

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 34
Devices cleared under the same product code (ELR) and FDA review panel - the closest regulatory comparables to K003219.
FRC POSTEC
K013802 · Ivoclar Vivadent, Inc. · May 2002
GLASS POST
K012849 · J. Morita USA, Inc. · Mar 2002
SNOWPOST, SNOWLIGHT
K012354 · Danville Materials, Inc. · Oct 2001
HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST
K003221 · Harald Nordin S.A · Oct 2000
TENAX WHITE POST
K993545 · Coltene/Whaledent, Inc. · Apr 2000
PARAPOST FIBER WHITE
K000311 · Coltene/Whaledent, Inc. · Mar 2000
K003219 · HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST
Download PDF FDA Summary Harald Nordin S.A