Cleared Traditional

K973765 - BIO-2000

K973765 is an FDA 510(k) clearance for BIO-2000, manufactured by Micrylium Laboratories. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 398-day FDA review.

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

FDA 510(k) Submission Details - K973765

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 127d · This submission: 398d
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 110
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K973765.
PLANMECA INTRACAM STATION
K984013 · Planmeca Oy · Jan 1999
S555 INTRAORAL DENTAL CAMERA
K983625 · Sopro · Jan 1999
SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES
K983242 · Sirona Dental Systems GmbH · Dec 1998
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
ULTRACAM
K973410 · W. Edward Johansen · Oct 1998
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
K981937 · Welch Allyn, Inc. · Aug 1998