Cleared Special

DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE (K992893) - FDA 510(k) Clearance

Class I Dental device.

K992893 · Mrlb Intl., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
12d
Days
Class 1
Risk

K992893 is an FDA 510(k) clearance for the DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Mrlb Intl., Inc. (Fergus Falls, US). The FDA issued a Cleared decision on September 8, 1999 after a review of 12 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mrlb Intl., Inc. devices

Submission Details

510(k) Number K992893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1999
Decision Date September 08, 1999
Days to Decision 12 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 127d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

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 K992893.
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MOBILE UNITS, I,II,III,IV
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