Cleared Traditional

K070297 - CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT

K070297 is an FDA 510(k) clearance for CLEARVIEW DENTAL HANDPIECE LUBRICATOR A..., manufactured by Dental Air Solutions of Nc, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 5-day FDA review.

K070297 · Dental Air Solutions of Nc, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
5d
Days
Class 1
Risk

K070297 is an FDA 510(k) clearance for the CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dental Air Solutions of Nc, Inc. (Holly Springs, US). The FDA issued a Cleared decision on February 5, 2007 after a review of 5 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Dental Air Solutions of Nc, Inc. devices

FDA 510(k) Submission Details - K070297

510(k) Number K070297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2007
Decision Date February 05, 2007
Days to Decision 5 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 127d · This submission: 5d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EFB Handpiece, Air-powered, Dental

All 138
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I-SURGE
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