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3D Dental
Model EN23 · 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · DI 00817169024293
DZM — Needle, Dental · Class I · 21 CFR 872.4730
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)
2019-05
0
1
2019-07
0
1
2019-09
0
1.5
2019-10
0
2
2019-11
0
1
2020-01
0
1
2020-02
0
1
2020-08
0
1.5
2020-09
0
1
2021-02
0
1
2021-03
0
1
2021-05
0
2
2021-09
0
1
2021-10
0
3
2023-02
0
2
2023-07
0
2
2024-04
0
1
2024-10
0
1
2025-10
0
1
This device (reports/month)Average device in DZM (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC