Cleared Traditional

K192701 - DIBS (Digital Indirect Bonding System)

K192701 is an FDA 510(k) clearance for DIBS (Digital Indirect Bonding System), manufactured by Orthoselect, LLC. The device is a Class 2 Dental device with product code PNN cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K192701 · Orthoselect, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
207d
Days
Class 2
Risk

K192701 is an FDA 510(k) clearance for the DIBS (Digital Indirect Bonding System). Classified as Orthodontic Software (product code PNN), Class II - Special Controls.

Submitted by Orthoselect, LLC (American Fork, US). The FDA issued a Cleared decision on April 21, 2020 after a review of 207 days - an extended review cycle.

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 Orthoselect, LLC devices

FDA 510(k) Submission Details - K192701

510(k) Number K192701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2019
Decision Date April 21, 2020
Days to Decision 207 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
80d slower than avg
Panel avg: 127d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNN Device Classification - Class 2, Special Controls

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 Consultant

Emma International Consulting Group, Inc.
Carmine Jabri

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 - PNN Orthodontic Software

All 30
Devices cleared under the same product code (PNN) and FDA review panel - the closest regulatory comparables to K192701.
AUTOLIGN
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BRUIS Software Suite
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CS Model+
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3Shape Splint Design
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