Cleared Traditional

K191911 - 3Shape Splint Design

K191911 is the FDA 510(k) clearance for 3Shape Splint Design by 3Shape A/S. It is a Class 2 Dental device (product code PNN) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K191911 · 3Shape A/S · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
133d
Days
Class 2
Risk

K191911 is an FDA 510(k) clearance for the 3Shape Splint Design. Classified as Orthodontic Software (product code PNN), Class II - Special Controls.

Submitted by 3Shape A/S (Copenhagen, DK). The FDA issued a Cleared decision on November 27, 2019 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - 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 A/S devices

Submission Details

510(k) Number K191911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2019
Decision Date November 27, 2019
Days to Decision 133 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
6d slower than avg
Panel avg: 127d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNN Orthodontic Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only.
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 - PNN Orthodontic Software

All 30
Devices cleared under the same product code (PNN) and FDA review panel - the closest regulatory comparables to K191911.
DIBS (Digital Indirect Bonding System)
K192701 · Orthoselect, LLC · Apr 2020
BRUIS Software Suite
K191720 · Mechanodontics, Inc. · Apr 2020
CS Model+
K193390 · Trophy · Apr 2020
OrthoAnalysis Software
K183695 · Inteware Co., Ltd. · Sep 2019
Orchestrate 3D
K181112 · Orchestrate 3D · Nov 2018
Ortho System
K180941 · 3Shape A/S · Oct 2018