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"1.2MM/.048"" HEX"
Model 83-7024 · W.H. Holden, Inc. · DI D9288370240
DZN — Instruments, Dental Hand · Class I · 21 CFR 872.4565
UDILibrary device dossier · generated 2026-09-07 · 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)
2019-02
0
10
2020-04
0
2
2020-05
0
2
2020-07
0
2
2021-01
0
2
2022-11
0
1
2023-02
0
1
2023-03
0
1
2023-04
0
1
2023-05
0
3
2023-06
0
1
2023-07
0
1
2023-08
0
2
2023-09
0
1
2023-10
0
1.33
2023-11
0
1
2024-01
0
1.6
2024-02
0
1
2024-03
0
1
2024-04
0
1.25
2024-05
0
3
2024-06
0
2
2024-07
0
2
2024-08
0
1.75
2024-09
0
1
2024-10
0
1
2024-11
0
1
2024-12
0
1.5
2025-02
0
1
2025-03
0
1
2025-04
0
1
2025-05
0
1
2025-07
0
1.5
2025-08
0
2
2025-10
0
1
2025-11
0
1.5
2025-12
0
1
2026-01
0
1
2026-02
0
1
2026-03
0
2.67
2026-04
0
3.5
2026-05
0
6.8
2026-06
0
4.57
This device (reports/month)Average device in DZN (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — W.H. Holden, Inc.