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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 128d · 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 Consultant

Air Techniques, Inc.
Pablo Martinez

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 - NBL Laser, Fluorescence Caries Detection

All 23
Devices cleared under the same product code (NBL) and FDA review panel - the closest regulatory comparables to K150672.
IC-WHCD100 (Inspire)
K183471 · Good Doctors Co., Ltd. · Jul 2020
Fluorescence Mode
K171007 · Carl Zeiss Suzhou Co., Ltd. · May 2018
Electronic Caries Detector
K170822 · Ortek Therapeutics, Inc. · Sep 2017
SOPROCARE
K121685 · Sopro · Mar 2013
THE CANARY SYSTEM
K112139 · Quantum Dental Technologies, Inc. · Oct 2012
CS 1600 INTRAORAL CAMERA
K111423 · Carestream Health, Inc. · Mar 2012