Cleared Traditional

SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE (K851524) - FDA 510(k) Clearance

Class I Dental device.

K851524 · Specialites Septodont · Dental device
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Sep 1985
Decision
160d
Days
Class 1
Risk

K851524 is an FDA 510(k) clearance for the SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE. Classified as Needle, Dental (product code DZM), Class I - General Controls.

Submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on September 23, 1985 after a review of 160 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4730 - 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 Specialites Septodont devices

Submission Details

510(k) Number K851524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1985
Decision Date September 23, 1985
Days to Decision 160 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 127d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DZM Needle, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4730
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.