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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 128d · 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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 247
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K070297.
A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT
K070663 · A-Dec, Inc. · Jul 2007
PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422
K070869 · Dentalez, Inc. · Jun 2007
LUBRINA, MODEL HIM-1
K070074 · J. Morita USA, Inc. · May 2007
MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE
K070001 · Mti Precision Products · Feb 2007
INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC
K070155 · Osseo Scientific, LLC · Jan 2007
HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES
K062947 · Peng Lim Enterprise Co., Ltd. · Dec 2006
K070297 · CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT
Download PDF FDA Summary Dental Air Solutions …