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3D Bond
Model DD-100 · AUGMA BIOMATERIALS LTD · DI 07290014838062
LYC — Bone Grafting Material, Synthetic · Class II · 21 CFR 872.3930
UDILibrary device dossier · generated 2026-09-14 · 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
6
2019-02
0
1.67
2019-09
0
1
2019-11
0
1
2019-12
0
1
2020-02
0
1
2020-03
0
1
2020-07
0
1
2020-08
0
1
2021-08
0
1
2022-01
0
1
2022-03
0
1
2022-07
0
1
2023-03
0
5
2023-06
0
2
2023-11
0
4
2024-07
0
1
2024-09
0
2
2024-11
0
1
2025-07
0
2
This device (reports/month)Average device in LYC (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K083858 — cited as predicate by K101014, K121177
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — AUGMA BIOMATERIALS LTD