Cleared Traditional

K072273 - BELMONT QUOLIS 5000 SERIES DENTAL UNIT (FDA 510(k) Clearance)

Class I Dental device.

K072273 · Takara Belmont USA, Inc. · Dental device
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Dec 2007
Decision
127d
Days
Class 1
Risk

K072273 is an FDA 510(k) clearance for the BELMONT QUOLIS 5000 SERIES DENTAL UNIT. Classified as Unit, Operative Dental, Accessories (product code NRD), Class I - General Controls.

Submitted by Takara Belmont USA, Inc. (West Cadwell, US). The FDA issued a Cleared decision on December 20, 2007 after a review of 127 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 Takara Belmont USA, Inc. devices

Submission Details

510(k) Number K072273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2007
Decision Date December 20, 2007
Days to Decision 127 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 127d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NRD Unit, Operative Dental, Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
Definition Air Compressor And Vacuum Unit That Are Connected To Dental Operative Unit To Provide Compressed Air And Vacuum Capability To Power And Drive Other Dental Devices, Which Are Attached To The Dental Operative Unit.
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.