Cleared Traditional

K150672 - VistaCam iX Proof

K150672 is an FDA 510(k) clearance for VistaCam iX Proof, manufactured by Durr Dental AG. The device is a Class 2 Dental device with product code NBL cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K150672 · Durr Dental AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
317d
Days
Class 2
Risk

K150672 is an FDA 510(k) clearance for the VistaCam iX Proof. Classified as Laser, Fluorescence Caries Detection (product code NBL), Class II - Special Controls.

Submitted by Durr Dental AG (Bietigheim-Bissingen, DE). The FDA issued a Cleared decision on January 27, 2016 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Durr Dental AG devices

FDA 510(k) Submission Details - K150672

510(k) Number K150672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2015
Decision Date January 27, 2016
Days to Decision 317 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
190d slower than avg
Panel avg: 127d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBL Device Classification - Class 2, Special Controls

Product Code NBL Laser, Fluorescence Caries Detection
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.

Regulatory Peers - NBL Laser, Fluorescence Caries Detection

All 14
Devices cleared under the same product code (NBL) and FDA review panel - the closest regulatory comparables to K150672.
L1P-1F (TRIOS 5)
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IC-WHCD100 (Inspire)
K183471 · Good Doctors Co., Ltd. · Jul 2020
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K171007 · Carl Zeiss Suzhou Co., Ltd. · May 2018
SOPROCARE
K121685 · Sopro · Mar 2013
CS 1600 INTRAORAL CAMERA
K111423 · Carestream Health, Inc. · Mar 2012
SOPROLIFE
K092583 · Sopro · Jan 2010