Cleared Traditional

K905011 - ORAL PHARYNGEAL CLEANSING DEVICE

K905011 is an FDA 510(k) clearance for ORAL PHARYNGEAL CLEANSING DEVICE, manufactured by Concord/Portex. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K905011 · Concord/Portex · Dental device
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Jan 1991
Decision
85d
Days
Class 1
Risk

K905011 is an FDA 510(k) clearance for the ORAL PHARYNGEAL CLEANSING DEVICE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Concord/Portex (Keene, US). The FDA issued a Cleared decision on January 31, 1991 after a review of 85 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 Concord/Portex devices

FDA 510(k) Submission Details - K905011

510(k) Number K905011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date January 31, 1991
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
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 100
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K905011.
A-DEC 3127 ASSISTANT'S WALLMOUNT
K933168 · A-Dec, Inc. · Oct 1993
MDT/CASTLE PURUS DENTAL UNIT
K914697 · Mdt Corp., Inc. · Nov 1991
ASEPTIMINI UNIT, ADU-10
K905401 · Aseptico, Inc. · Feb 1991
A-DEC PAC I PORTABLE UNIT
K903451 · A-Dec, Inc. · Oct 1990
A-DEC IC CONTROL HEAD
K903452 · A-Dec, Inc. · Oct 1990
A-DEC IC MICRO-CART
K903453 · A-Dec, Inc. · Oct 1990