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25K FS-SLIM PLASTIC INSERT
Model TM0004-782R · BONART CO., LTD. · DI 04719873120130
ELC — Scaler, Ultrasonic · Class II · 21 CFR 872.4850
UDILibrary device dossier · generated 2026-09-06 · 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
2019-02
0
3
2019-03
0
2
2019-04
0
1.4
2019-05
0
1.56
2019-06
0
3
2019-07
0
1.67
2019-08
0
2.6
2019-09
0
1.4
2019-10
0
1
2019-12
0
1.67
2020-01
0
1.5
2020-02
0
1.67
2020-03
0
2.67
2020-04
0
1.6
2020-06
0
1
2020-07
0
1.5
2020-08
0
1
2020-09
0
1
2020-10
0
1.67
2020-11
0
1.75
2021-01
0
1.33
2021-02
0
1.67
2021-03
0
2
2021-04
0
1
2021-05
0
1
2021-06
0
1
2021-07
0
3
2021-08
0
5
2021-09
0
1
2021-10
0
1
2021-12
0
1
2022-01
0
1.17
2022-02
0
3
2022-03
0
2
2022-04
0
3
2022-05
0
2.2
2022-07
0
1
2022-09
0
2.8
2022-10
0
1
2023-02
0
1
2023-03
0
1.2
2023-04
0
1.67
2023-05
0
1.43
2023-06
0
1.67
2023-07
0
1.6
2023-08
0
1.14
2023-09
0
1.83
2023-10
0
1.75
2023-11
0
1.5
2023-12
0
1.5
2024-01
0
1.75
2024-02
0
1.33
2024-03
0
1.5
2024-04
0
1.36
2024-05
0
2.31
2024-06
0
1.64
2024-07
0
1.25
2024-08
0
1.22
2024-09
0
1.62
2024-10
0
1.87
2024-11
0
1.86
2024-12
0
1.89
2025-01
0
2
2025-02
0
2
2025-03
0
1.33
2025-04
0
2.09
2025-05
0
2.15
2025-06
0
2.27
2025-07
0
1.6
2025-08
0
2.08
2025-09
0
2.25
2025-10
0
2.1
2025-11
0
2
2025-12
0
1.65
2026-01
0
1.67
2026-02
0
1.53
2026-03
0
2.23
2026-04
0
1.9
2026-05
0
1.93
2026-06
0
3.36
This device (reports/month)Average device in ELC (reports/device/month)