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"Instrument Set ""Special"""
Model 07173200 · W & H Dentalwerk Bürmoos GmbH · DI J021071732009
DZI — Drill, Bone, Powered · Class II · 21 CFR 872.4120
ELC — Scaler, Ultrasonic · Class II · 21 CFR 872.4850
UDILibrary device dossier · generated 2026-09-11 · 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
2
2019-02
0
2.33
2019-03
0
2.33
2019-04
0
1.89
2019-05
0
1.89
2019-06
0
3
2019-07
0
2.83
2019-08
0
3.17
2019-09
0
2.5
2019-10
0
2.11
2019-11
0
1.88
2019-12
0
2.92
2020-01
0
2.17
2020-02
0
2
2020-03
0
3
2020-04
0
1.75
2020-05
0
2.67
2020-06
0
3.2
2020-07
0
2.67
2020-08
0
2
2020-09
0
3.45
2020-10
0
3.29
2020-11
0
2.77
2020-12
0
3.67
2021-01
0
2.5
2021-02
0
2.13
2021-03
0
2.13
2021-04
0
2.27
2021-05
0
2
2021-06
0
3.77
2021-07
0
3.56
2021-08
0
3
2021-09
0
1.85
2021-10
0
1.57
2021-11
0
4.25
2021-12
0
2.64
2022-01
0
4
2022-02
0
2.38
2022-03
0
2.36
2022-04
0
1.63
2022-05
0
2.07
2022-06
0
2.78
2022-07
0
2.77
2022-08
0
2.89
2022-09
0
5
2022-10
0
2.18
2022-11
0
2.67
2022-12
0
3.2
2023-01
0
2.89
2023-02
0
3
2023-03
0
2.5
2023-04
0
2.75
2023-05
0
2.42
2023-06
0
2.13
2023-07
0
2.36
2023-08
0
1.87
2023-09
0
1.8
2023-10
0
1.88
2023-11
0
1.95
2023-12
0
1.88
2024-01
0
2.46
2024-02
0
1.88
2024-03
0
2.25
2024-04
0
1.67
2024-05
0
2.26
2024-06
0
2.39
2024-07
0
1.83
2024-08
0
1.79
2024-09
0
2.13
2024-10
0
2.3
2024-11
0
2.2
2024-12
0
1.92
2025-01
0
2.54
2025-02
0
2
2025-03
0
2.3
2025-04
0
2
2025-05
0
2.72
2025-06
0
2.35
2025-07
0
1.57
2025-08
0
2.29
2025-09
0
2.5
2025-10
0
2.2
2025-11
0
2.33
2025-12
0
1.71
2026-01
0
1.74
2026-02
0
1.68
2026-03
0
2.11
2026-04
0
2.41
2026-05
0
2.35
2026-06
0
3
This device (reports/month)Average device in DZI, ELC (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — W & H Dentalwerk Bürmoos GmbH