Cleared Traditional

K802811 - MONOJECT ROOT CANAL FILLING MAT. NEEDLE (FDA 510(k) Clearance)

Class I Dental device.

K802811 · Sherwood Medical Co. · Dental device
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Nov 1980
Decision
17d
Days
Class 1
Risk

K802811 is an FDA 510(k) clearance for the MONOJECT ROOT CANAL FILLING MAT. NEEDLE. Classified as Needle, Dental (product code DZM), Class I - General Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on November 24, 1980 after a review of 17 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sherwood Medical Co. devices

Submission Details

510(k) Number K802811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1980
Decision Date November 24, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 127d · This submission: 17d
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.