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AMADEO M-UK1023
Model 30387000 · W & H Dentalwerk Bürmoos GmbH · DI J021303870001
DZI — Drill, Bone, Powered · Class II · 21 CFR 872.4120
ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece · Class II · 21 CFR 874.4250
GEY — Motor, Surgical Instrument, Ac-Powered · Class I · 21 CFR 878.4820
HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment · Class I · 21 CFR 878.4820
UDILibrary device dossier · generated 2026-09-14 · 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
3.25
2019-02
0
3.77
2019-03
0
5.69
2019-04
0
4.9
2019-05
0
4.43
2019-06
0
4.64
2019-07
0
4.07
2019-08
0
5.5
2019-09
0
4.63
2019-10
0
4.37
2019-11
0
5.08
2019-12
0
5.75
2020-01
0
4.5
2020-02
0
4.27
2020-03
0
5.53
2020-04
0
4
2020-05
0
3.42
2020-06
0
5.48
2020-07
0
4.55
2020-08
0
4.39
2020-09
0
4.81
2020-10
0
4.58
2020-11
0
5.03
2020-12
0
5.16
2021-01
0
4.38
2021-02
0
5.01
2021-03
0
5.22
2021-04
0
4.25
2021-05
0
4.42
2021-06
0
5.15
2021-07
0
4.06
2021-08
0
4.57
2021-09
0
4.01
2021-10
0
3.15
2021-11
0
3.88
2021-12
0
4.11
2022-01
0
3.64
2022-02
0
3.63
2022-03
0
4.1
2022-04
0
3.58
2022-05
0
3.49
2022-06
0
4.78
2022-07
0
4.02
2022-08
0
4.36
2022-09
0
4.9
2022-10
0
4.04
2022-11
0
4.59
2022-12
0
5.28
2023-01
0
3.33
2023-02
0
4.31
2023-03
0
4.47
2023-04
0
3.68
2023-05
0
5.25
2023-06
0
4.41
2023-07
0
4.02
2023-08
0
3.96
2023-09
0
3.94
2023-10
0
3.08
2023-11
0
4.59
2023-12
0
3.62
2024-01
0
3.65
2024-02
0
4.65
2024-03
0
4.08
2024-04
0
3.78
2024-05
0
3.94
2024-06
0
4.44
2024-07
0
3.36
2024-08
0
3.48
2024-09
0
4.89
2024-10
0
3.72
2024-11
0
3.56
2024-12
0
3.53
2025-01
0
3.26
2025-02
0
5.19
2025-03
0
4.37
2025-04
0
2.78
2025-05
0
4.52
2025-06
0
3.98
2025-07
0
3.56
2025-08
0
3.5
2025-09
0
3.18
2025-10
0
3.07
2025-11
0
3.86
2025-12
0
3.8
2026-01
0
2.99
2026-02
0
3.29
2026-03
0
3.44
2026-04
0
4.72
2026-05
0
3.92
2026-06
0
4.01
This device (reports/month)Average device in DZI, ERL, GEY, HWE (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — W & H Dentalwerk Bürmoos GmbH