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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 128d · 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 Consultant

Acknowledge Regulatory Strategies
Allison Komiyama

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 K170822.
L1P-1F (TRIOS 5)
K221249 · 3Shape TRIOS A/S · Sep 2022
IC-WHCD100 (Inspire)
K183471 · Good Doctors Co., Ltd. · Jul 2020
Fluorescence Mode
K171007 · Carl Zeiss Suzhou Co., Ltd. · May 2018
VistaCam iX Proof
K150672 · Durr Dental AG · Jan 2016
SOPROCARE
K121685 · Sopro · Mar 2013
THE CANARY SYSTEM
K112139 · Quantum Dental Technologies, Inc. · Oct 2012