Cleared Traditional

BIO-2000 (K973765) - FDA 510(k) Clearance

Class I Dental device.

K973765 · Micrylium Laboratories · Dental device
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Nov 1998
Decision
398d
Days
Class 1
Risk

K973765 is an FDA 510(k) clearance for the BIO-2000. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Micrylium Laboratories (Temple, US). The FDA issued a Cleared decision on November 4, 1998 after a review of 398 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Micrylium Laboratories devices

Submission Details

510(k) Number K973765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1997
Decision Date November 04, 1998
Days to Decision 398 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
271d slower than avg
Panel avg: 127d · This submission: 398d
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 K973765.
P50 Series Dental Operative Unit and Accessories
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ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
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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
MOBILE UNITS, I,II,III,IV
K790112 · Dentsply Intl. · Feb 1979