Print-ready dossier — use your browser's print dialog to save as PDF.
Blue Sky Bio, LLC.
Model 4.12 · BLUE SKY BIO LLC · DI 00815131026726
DYW — Bracket, Plastic, Orthodontic · Class II · 21 CFR 872.5470
LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050
NOF — System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations · Class II · 21 CFR 872.3661
NXC — Aligner, Sequential · Class II · 21 CFR 872.5470
PNN — Orthodontic Software · Class II · 21 CFR 872.5470
PZY — Additively Manufactured, Preformed, Resin Denture Tooth · Class II · 21 CFR 872.3590
UDILibrary device dossier · generated 2026-09-16 · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
5
2019-02
0
11.5
2019-03
0
8.71
2019-04
0
7.44
2019-05
0
15.67
2019-06
0
11
2019-07
0
8.25
2019-08
0
24.67
2019-09
0
9.5
2019-10
0
9
2019-11
0
9.5
2019-12
0
13.67
2020-01
0
4.38
2020-02
0
10.4
2020-03
0
9.08
2020-04
0
14.75
2020-05
0
5.5
2020-06
0
2.6
2020-07
0
3.6
2020-08
0
3.21
2020-09
0
1.81
2020-10
0
2.82
2020-11
0
2.33
2020-12
0
3.4
2021-01
0
2.91
2021-02
0
2.11
2021-03
0
3.14
2021-04
0
2.71
2021-05
0
3.73
2021-06
0
2.8
2021-07
0
6.81
2021-08
0
4.8
2021-09
0
3.93
2021-10
0
4.35
2021-11
0
3.05
2021-12
0
3.94
2022-01
0
3.5
2022-02
0
2.7
2022-03
0
4.33
2022-04
0
3.19
2022-05
0
4.31
2022-06
0
5.68
2022-07
0
5.73
2022-08
0
7.22
2022-09
0
5.9
2022-10
0
3.8
2022-11
0
3
2022-12
0
2.59
2023-01
0
3.22
2023-02
0
2.96
2023-03
0
2.37
2023-04
0
2.17
2023-05
0
1.63
2023-06
0
3.12
2023-07
0
2.22
2023-08
0
2.5
2023-09
0
2.13
2023-10
0
2.65
2023-11
0
2.03
2023-12
0
1.74
2024-01
0
2
2024-02
0
2.7
2024-03
0
2.52
2024-04
0
4.36
2024-05
0
2.53
2024-06
0
2.31
2024-07
0
10.96
2024-08
0
22.97
2024-09
0
106.82
2024-10
0
162.43
2024-11
0
647.07
2024-12
0
312.04
2025-01
0
159.84
2025-02
0
93.22
2025-03
0
64.5
2025-04
0
42.72
2025-05
0
47.58
2025-06
0
30.03
2025-07
0
20.05
2025-08
0
45.86
2025-09
0
15.06
2025-10
0
15.15
2025-11
0
8.25
2025-12
0
18.09
2026-01
0
28.32
2026-02
0
18.43
2026-03
0
268.95
2026-04
0
17.76
2026-05
0
19.21
2026-06
0
11.39
This device (reports/month)Average device in DYW, LLZ, NOF, NXC, PNN, PZY (reports/device/month)