Cleared Special

K992868 - DENTAPURE DP40 CARTRIDGE

K992868 is an FDA 510(k) clearance for DENTAPURE DP40 CARTRIDGE, manufactured by Mrlb Intl., Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Special 510(k) pathway after a 12-day FDA review.

K992868 · Mrlb Intl., Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
12d
Days
Class 1
Risk

K992868 is an FDA 510(k) clearance for the DENTAPURE DP40 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 7, 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.

FDA 510(k) Submission Details - K992868

510(k) Number K992868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1999
Decision Date September 07, 1999
Days to Decision 12 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 128d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

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 272
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K992868.
STERLTECH WATER PURIFIER
K000941 · Sterltech, Inc. · 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
ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L
K991946 · Sterilex Corp. · Sep 1999
DIFOTI SYSTEM
K991098 · Electro-Optical Sciences, Inc. · Jun 1999
QUANTEC-E IRRIGATION SYSTEM
K991035 · Sybron Dental Specialties, Inc. · Jun 1999
K992868 · DENTAPURE DP40 CARTRIDGE
Download PDF FDA Summary Mrlb Intl., Inc.