Cleared Special

HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST (K003221) - FDA 510(k) Clearance

Class I Dental device.

K003221 · Harald Nordin S.A · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
9d
Days
Class 1
Risk

K003221 is an FDA 510(k) clearance for the HARALD NORDIN GLASSIX GLASS 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.

View all Harald Nordin S.A devices

Submission Details

510(k) Number K003221 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
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 127d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

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.