Cleared Special

K051010 - SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K051010 · Septodont · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
11d
Days
Class 2
Risk

K051010 is an FDA 510(k) clearance for the SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Septodont (Washington, US). The FDA issued a Cleared decision on May 2, 2005 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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 Septodont devices

Submission Details

510(k) Number K051010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2005
Decision Date May 02, 2005
Days to Decision 11 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 127d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EJJ Alloy, Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.