Cleared Traditional

K000941 - STERLTECH WATER PURIFIER

K000941 is an FDA 510(k) clearance for STERLTECH WATER PURIFIER, manufactured by Sterltech, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K000941 · Sterltech, Inc. · Dental device
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Apr 2000
Decision
14d
Days
Class 1
Risk

K000941 is an FDA 510(k) clearance for the STERLTECH WATER PURIFIER. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Sterltech, Inc. (Waterbury, US). The FDA issued a Cleared decision on April 6, 2000 after a review of 14 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sterltech, Inc. devices

FDA 510(k) Submission Details - K000941

510(k) Number K000941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2000
Decision Date April 06, 2000
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 127d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 174
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K000941.
4635 ASSISTANT'S INSTRUMENTATION
K000967 · A-Dec, Inc. · May 2000
3181 DUO DELIVERY SYSTEM
K000968 · A-Dec, Inc. · May 2000
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
K000112 · Dentsply Intl. · Apr 2000
QUANTEC-E IRRIGATION SYSTEM 2
K992195 · Sybron Dental Specialties, Inc. · Oct 1999
DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE
K992893 · Mrlb Intl., Inc. · Sep 1999
DENTAPURE DP40 CARTRIDGE
K992868 · Mrlb Intl., Inc. · Sep 1999