Cleared Traditional

K033925 - BIOFREE

K033925 is an FDA 510(k) clearance for BIOFREE, manufactured by Dental Components, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K033925 · Dental Components, Inc. · Dental device
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Apr 2004
Decision
111d
Days
Class 1
Risk

K033925 is an FDA 510(k) clearance for the BIOFREE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Dental Components, Inc. (Newberg, US). The FDA issued a Cleared decision on April 7, 2004 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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.

FDA 510(k) Submission Details - K033925

510(k) Number K033925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2003
Decision Date April 07, 2004
Days to Decision 111 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 128d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.

Regulatory Peers - EIA Unit, Operative Dental

All 255
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K033925 · BIOFREE
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