Cleared Traditional

K071429 - TI2200 TRANSILLUMINATION CABLE

K071429 is an FDA 510(k) clearance for TI2200 TRANSILLUMINATION CABLE, manufactured by Kerr Corporation. The device is a Class 2 Dental device with product code NTK cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K071429 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
110d
Days
Class 2
Risk

K071429 is an FDA 510(k) clearance for the TI2200 TRANSILLUMINATION CABLE. Classified as Caries Detector, Laser Light, Transmission (product code NTK), Class II - Special Controls.

Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on September 10, 2007 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1745 - 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 Kerr Corporation devices

FDA 510(k) Submission Details - K071429

510(k) Number K071429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2007
Decision Date September 10, 2007
Days to Decision 110 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
17d faster than avg
Panel avg: 127d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NTK Device Classification - Class 2, Special Controls

Product Code NTK Caries Detector, Laser Light, Transmission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1745
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.