Cleared Traditional

BIOFREE (K033925) - FDA 510(k) Clearance

Class I Dental device.

K033925 · Dental Components, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Dental Components, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 127d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 25
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K033925.
Qraypen
K183121 · AIOBIO Co., Ltd. · Jul 2019
Forest Dental Unit
K173608 · Forest Dental Products, Inc. · Aug 2018
P50 Series Dental Operative Unit and Accessories
K171872 · Pelton & Crane · Apr 2018
ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
K032904 · Dentsply Intl. · Oct 2003
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
K000112 · Dentsply Intl. · Apr 2000
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998