Arcad Aligners
Model Clear Orthodontic Aligners · ARCADLAB · DI 00860011071921
NXC — Aligner, Sequential · Class II · 21 CFR 872.5470
PNN — Orthodontic Software · Class II · 21 CFR 872.5470
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-07 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-05 | 0 | 2 |
| 2020-08 | 0 | 1 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-11 | 0 | 2 |
| 2021-02 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-05 | 0 | 1 |
| 2021-06 | 0 | 1 |
| 2021-07 | 0 | 13.5 |
| 2021-08 | 0 | 6.67 |
| 2021-09 | 0 | 5.57 |
| 2021-10 | 0 | 5.5 |
| 2021-11 | 0 | 2.64 |
| 2021-12 | 0 | 3 |
| 2022-01 | 0 | 3.8 |
| 2022-02 | 0 | 2.5 |
| 2022-03 | 0 | 5.22 |
| 2022-04 | 0 | 4.23 |
| 2022-05 | 0 | 7.57 |
| 2022-06 | 0 | 7.36 |
| 2022-07 | 0 | 8.21 |
| 2022-08 | 0 | 10.69 |
| 2022-09 | 0 | 8 |
| 2022-10 | 0 | 4.06 |
| 2022-11 | 0 | 3.64 |
| 2022-12 | 0 | 3.27 |
| 2023-01 | 0 | 4.08 |
| 2023-02 | 0 | 3.55 |
| 2023-03 | 0 | 2.25 |
| 2023-04 | 0 | 2 |
| 2023-05 | 0 | 1.71 |
| 2023-06 | 0 | 3.42 |
| 2023-07 | 0 | 1.45 |
| 2023-08 | 0 | 2.77 |
| 2023-09 | 0 | 2.2 |
| 2023-10 | 0 | 1.86 |
| 2023-11 | 0 | 1.79 |
| 2023-12 | 0 | 1.42 |
| 2024-01 | 0 | 1.88 |
| 2024-02 | 0 | 2.33 |
| 2024-03 | 0 | 1.6 |
| 2024-04 | 0 | 3.43 |
| 2024-05 | 0 | 2.17 |
| 2024-06 | 0 | 1.6 |
| 2024-07 | 0 | 32.43 |
| 2024-08 | 0 | 64.2 |
| 2024-09 | 0 | 417.29 |
| 2024-10 | 0 | 498.11 |
| 2024-11 | 0 | 1805.9 |
| 2024-12 | 0 | 931.56 |
| 2025-01 | 0 | 637 |
| 2025-02 | 0 | 283 |
| 2025-03 | 0 | 260.18 |
| 2025-04 | 0 | 132.11 |
| 2025-05 | 0 | 250.5 |
| 2025-06 | 0 | 108.9 |
| 2025-07 | 0 | 59.75 |
| 2025-08 | 0 | 171.29 |
| 2025-09 | 0 | 51.67 |
| 2025-10 | 0 | 34.33 |
| 2025-11 | 0 | 21.7 |
| 2025-12 | 0 | 63.44 |
| 2026-01 | 0 | 94.33 |
| 2026-02 | 0 | 44.5 |
| 2026-03 | 0 | 1184.5 |
| 2026-04 | 0 | 41.75 |
| 2026-05 | 0 | 18.82 |
| 2026-06 | 0 | 13.5 |
Regulatory clearances
- K192244 SESE 2020-05-11 (k number procode)
Predicate lineage
K192244 — cites (transitively): K080227 (d1), K113618 (d1), K180941 (d1), K082556 (d2), K093821 (d2), K062828 (d2), K163677 (d2), K171295 (d2), K171634 (d2), K152086 (d3), K161884 (d3), K082207 (d4), K110430 (d4) — cited as predicate by K203737, K210613, K221845
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — ARCADLAB
- NAI 2025-02-05 ARCADLAB, LLC · 0 citations
- VAI 2023-09-01 ARCADLAB, LLC · 3 citations