Cleared Traditional

K963548 - DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED

K963548 is an FDA 510(k) clearance for DENTAPURE DENTAL UNIT WATER LINE FILTER..., manufactured by Mrlb Intl., Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K963548 · Mrlb Intl., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
139d
Days
Class 1
Risk

K963548 is an FDA 510(k) clearance for the DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Mrlb Intl., Inc. (East Grand Forks, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 139 days - within the typical 510(k) review window.

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 Mrlb Intl., Inc. devices

FDA 510(k) Submission Details - K963548

510(k) Number K963548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1996
Decision Date January 22, 1997
Days to Decision 139 days
Submission Type Traditional
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
12d slower than avg
Panel avg: 127d · This submission: 139d
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 154
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K963548.
ODYSSEY I DENTAL WATER UNIT
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STERILE WATER PUMP
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DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)
K964619 · Sds Dental, Inc. · Jan 1997
CDR-CAM
K963778 · Schick Technologies, Inc. · Nov 1996
PROSTYLE COMPACT
K961420 · Planmeca Oy · Sep 1996