NemoCast

FDA 510(k) K193003 · Software Nemotec S.L.

Substantially Equivalent

510(k) numberK193003

Submission

Device name
NemoCast
Applicant
Software Nemotec S.L.
Arroyomolinos, Madrid, ES
Received
October 28, 2019
Decision date
June 5, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
PNN – Orthodontic Software
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5470
Specialty
Dental

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.

Other 510(k)s with product code PNN

510(k)DeviceApplicantDecision
K260419LingOral Dental Design SystemPNN · Traditional Hangzhou ChohoTech Co., Ltd.05/08/2026SE
K253565SureSmile SoftwarePNN · Traditional Dentsply Sirona, Inc.03/04/2026SE
K252507SmileInspectorPNN · Traditional Amv Consulting, LLC01/07/2026SE
K253343Celebrace SoftwarePNN · Traditional Celebrace12/29/2025SE
K250198Laon OrthoPNN · Traditional Laon Medi, Inc.04/23/2025SE
K241153Progressive Orthodontics AppPNN · Traditional Progressive Aligners, Inc.10/11/2024SE
K233625Raydent SWPNN · Traditional Ray Co., Ltd.05/16/2024SE
K232564Align StudioPNN · Traditional Laon Medi, Inc.03/12/2024SE
K233616Clevaligner Software (V1.0.0)PNN · Traditional Clevaligner, Ltd.01/11/2024SE
K232549NemoCastPNN · Traditional Software Nemotec S.L.11/21/2023SE

More from Software Nemotec S.L.

510(k)DeviceDecision
K232698NemoScanQIH · Traditional 01/18/2024SE
K232549NemoCastPNN · Traditional 11/21/2023SE
K192475NemoFABLLZ · Traditional 04/23/2020SE
K192571NemoScanLLZ · Traditional 12/11/2019SE

Questions and answers

When was NemoCast cleared by the FDA?

NemoCast (K193003) received a 510(k) decision of Substantially Equivalent on June 5, 2020, 221 days after the submission was received.

What is the product code of K193003?

The FDA product code is PNN – Orthodontic Software, a Class II (moderate risk) device regulated under 21 CFR 872.5470.