← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

PNN — Orthodontic Software

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 872.5470
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES

Recent clearances

K260419Hangzhou ChohoTech Co., Ltd. · 510k2026-05-08
K253565Dentsply Sirona, Inc. · 510k2026-03-04
K252507Amv Consulting, LLC · 510k2026-01-07
K253343Celebrace · 510k2025-12-29
K250198Laon Medi, Inc. · 510k2025-04-23
K241153Progressive Aligners, Inc. · 510k2024-10-11

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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