← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
NXC — Aligner, Sequential
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.
DEVICE CLASS
Class II
REGULATION
21 CFR 872.5470
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
20
510(K)/PMA CLEARANCES
510k: 20
0
RECALL ENTRIES
Recent clearances
K260527Avinent Implant System S.L.U. · 510k2026-07-02
K260788Smylio, Inc. · 510k2026-05-08
K260722Dentsply Sirona, Inc. · 510k2026-04-15
K253282Dror Orthodesign , Ltd. · 510k2026-02-03
K251454Beame Medical Technology (Shenzhen) Limited · 510k2026-01-07
K250739Dreve Dentamid GmbH · 510k2025-11-07
K252931Align Technology, Inc. · 510k2025-10-23
K252870Align Technology, Inc. · 510k2025-10-09
Related on SPEQ
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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