Cleared Traditional

K221249 - L1P-1F (TRIOS 5)

K221249 is an FDA 510(k) clearance for L1P-1F (TRIOS 5), manufactured by 3Shape TRIOS A/S. The device is a Class 2 Dental device with product code NBL cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K221249 · 3Shape TRIOS A/S · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
137d
Days
Class 2
Risk

K221249 is an FDA 510(k) clearance for the L1P-1F (TRIOS 5). Classified as Laser, Fluorescence Caries Detection (product code NBL), Class II - Special Controls.

Submitted by 3Shape TRIOS A/S (Copenhagen, DK). The FDA issued a Cleared decision on September 16, 2022 after a review of 137 days - within the typical 510(k) review window.

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 3Shape TRIOS A/S devices

FDA 510(k) Submission Details - K221249

510(k) Number K221249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2022
Decision Date September 16, 2022
Days to Decision 137 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
10d slower than avg
Panel avg: 127d · This submission: 137d
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 10
Devices cleared under the same product code (NBL) and FDA review panel - the closest regulatory comparables to K221249.
Qraycam PRO
K221275 · AIOBIO Co., Ltd. · Sep 2024
SmarTooth
K231722 · Smartooth Co., Ltd. · May 2024
C50
K223470 · Sopro · Dec 2023
IC-WHCD100 (Inspire)
K183471 · Good Doctors Co., Ltd. · Jul 2020
Fluorescence Mode
K171007 · Carl Zeiss Suzhou Co., Ltd. · May 2018
SOPROCARE
K121685 · Sopro · Mar 2013