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Symbios ™
Model PepGen P-15 Particulate · Dentsply Implants Manufacturing GmbH · DI EFRIUS99U000102
NPZ — Bone Grafting Material, Dental, With Biologic Component · Class III · 21 CFR 872.3930
UDILibrary device dossier · generated 2026-09-13 · 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
1
2019-04
0
1
2019-05
0
2
2019-07
0
1.5
2019-08
0
1.5
2020-01
0
2
2020-02
0
1
2020-08
0
2
2020-09
0
3
2020-10
0
3
2021-02
0
2
2021-03
0
1.5
2021-09
0
2
2022-01
0
4
2022-07
0
2
2022-10
0
2
2023-10
0
2
2024-03
0
2
2024-06
0
2
2024-07
0
2
2025-04
0
2
2025-07
0
1
2025-08
0
1
2025-09
0
2
2025-10
0
3
2026-01
0
1
2026-03
0
3
2026-05
0
2
2026-06
0
2
This device (reports/month)Average device in NPZ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Dentsply Implants Manufacturing GmbH