Cleared Traditional

K851524 - SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE

K851524 is an FDA 510(k) clearance for SEPTOJECT STERILE DISPOSABLE INJECTION ..., manufactured by Specialites Septodont. The device is a Class 1 Dental device with product code DZM cleared through the Traditional 510(k) pathway after a 160-day FDA review.

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

FDA 510(k) Submission Details - K851524

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 127d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

DZM Device Classification - Class 1, General Controls

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.