Cleared Traditional

STERISIL ANTIMICROBIAL TUBING AND BOTTLE (K031681) - FDA 510(k) Clearance

Class I Dental device.

K031681 · Sterisil · Dental device
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Oct 2003
Decision
153d
Days
Class 1
Risk

K031681 is an FDA 510(k) clearance for the STERISIL ANTIMICROBIAL TUBING AND BOTTLE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Sterisil (Castle Rock, US). The FDA issued a Cleared decision on October 30, 2003 after a review of 153 days - an extended review cycle.

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 Sterisil devices

Submission Details

510(k) Number K031681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2003
Decision Date October 30, 2003
Days to Decision 153 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
26d slower than avg
Panel avg: 127d · This submission: 153d
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 K031681.
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KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998