Cleared Traditional

K170822 - Electronic Caries Detector

K170822 is an FDA 510(k) clearance for Electronic Caries Detector, manufactured by Ortek Therapeutics, Inc.. The device is a Class 2 Dental device with product code NBL cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K170822 · Ortek Therapeutics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
175d
Days
Class 2
Risk

K170822 is an FDA 510(k) clearance for the Electronic Caries Detector. Classified as Laser, Fluorescence Caries Detection (product code NBL), Class II - Special Controls.

Submitted by Ortek Therapeutics, Inc. (Roslyn Heights, US). The FDA issued a Cleared decision on September 11, 2017 after a review of 175 days - an extended review cycle.

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 Ortek Therapeutics, Inc. devices

FDA 510(k) Submission Details - K170822

510(k) Number K170822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2017
Decision Date September 11, 2017
Days to Decision 175 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
48d slower than avg
Panel avg: 127d · This submission: 175d
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 13
Devices cleared under the same product code (NBL) and FDA review panel - the closest regulatory comparables to K170822.
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SOPROCARE
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CS 1600 INTRAORAL CAMERA
K111423 · Carestream Health, Inc. · Mar 2012
SOPROLIFE
K092583 · Sopro · Jan 2010