Cleared Traditional

MINI-MILL (K914035) - FDA 510(k) Clearance

Class I Dental device.

K914035 · Biomedical Composites, Ltd. · Dental device
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Mar 1992
Decision
174d
Days
Class 1
Risk

K914035 is an FDA 510(k) clearance for the MINI-MILL. Classified as File, Bone, Surgical (product code EMI), Class I - General Controls.

Submitted by Biomedical Composites, Ltd. (Carpinteria, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 174 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Biomedical Composites, Ltd. devices

Submission Details

510(k) Number K914035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1991
Decision Date March 02, 1992
Days to Decision 174 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 127d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMI File, Bone, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.