Cleared Traditional

K121685 - SOPROCARE

K121685 is an FDA 510(k) clearance for SOPROCARE, manufactured by Sopro. The device is a Class 2 Dental device with product code NBL cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K121685 · Sopro · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
278d
Days
Class 2
Risk

K121685 is an FDA 510(k) clearance for the SOPROCARE. Classified as Laser, Fluorescence Caries Detection (product code NBL), Class II - Special Controls.

Submitted by Sopro (Mt. Laurel, US). The FDA issued a Cleared decision on March 12, 2013 after a review of 278 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 Sopro devices

FDA 510(k) Submission Details - K121685

510(k) Number K121685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2012
Decision Date March 12, 2013
Days to Decision 278 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
151d slower than avg
Panel avg: 127d · This submission: 278d
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 22
Devices cleared under the same product code (NBL) and FDA review panel - the closest regulatory comparables to K121685.
Fluorescence Mode
K171007 · Carl Zeiss Suzhou Co., Ltd. · May 2018
Electronic Caries Detector
K170822 · Ortek Therapeutics, Inc. · Sep 2017
VistaCam iX Proof
K150672 · Durr Dental AG · Jan 2016
THE CANARY SYSTEM
K112139 · Quantum Dental Technologies, Inc. · Oct 2012
CS 1600 INTRAORAL CAMERA
K111423 · Carestream Health, Inc. · Mar 2012
REMOTE VIEW SOFTWARE
K111321 · Cariescan , Ltd. · May 2011