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1 LB NEON PURPLE POWDER
Model 045-015 · Great Lakes Dental Technologies, Ltd. · DI D7750450150
EBI — Resin, Denture, Relining, Repairing, Rebasing · Class II · 21 CFR 872.3760
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-10 | 0 | 1 |
| 2022-07 | 0 | 1 |
| 2023-05 | 0 | 3 |
| 2023-10 | 0 | 1 |
| 2024-08 | 0 | 1 |
| 2025-03 | 0 | 7.33 |
| 2025-07 | 0 | 1 |
| 2026-03 | 0 | 1 |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — Great Lakes Dental Technologies, Ltd.
Nothing in the loaded window.