Cleared Traditional

MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS (K911111) - FDA 510(k) Clearance

Class I Dental device.

K911111 · Vermont Diamond Instruments · Dental device
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Nov 1991
Decision
257d
Days
Class 1
Risk

K911111 is an FDA 510(k) clearance for the MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS. Classified as Disk, Abrasive (product code EHJ), Class I - General Controls.

Submitted by Vermont Diamond Instruments (Bridgewater Corners, US). The FDA issued a Cleared decision on November 19, 1991 after a review of 257 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6010 - 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 Vermont Diamond Instruments devices

Submission Details

510(k) Number K911111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1991
Decision Date November 19, 1991
Days to Decision 257 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 127d · This submission: 257d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EHJ Disk, Abrasive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6010
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.