Cleared Traditional

K964942 - INFECTION CONTROL CARTRIDGE

K964942 is an FDA 510(k) clearance for INFECTION CONTROL CARTRIDGE, manufactured by Dentalpure Corp.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K964942 · Dentalpure Corp. · Dental device
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Jun 1997
Decision
191d
Days
Class 1
Risk

K964942 is an FDA 510(k) clearance for the INFECTION CONTROL CARTRIDGE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Dentalpure Corp. (St. Paul, US). The FDA issued a Cleared decision on June 19, 1997 after a review of 191 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 Dentalpure Corp. devices

FDA 510(k) Submission Details - K964942

510(k) Number K964942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1996
Decision Date June 19, 1997
Days to Decision 191 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
64d slower than avg
Panel avg: 127d · This submission: 191d
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 109
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K964942.
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ODYSSEY I DENTAL WATER UNIT
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K970626 · I.C.S. · Apr 1997