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Bionnovation Gide XP
Model 502170 · Geistlich Pharma AG · DI 07610221017645
NPL — Barrier, Animal Source, Intraoral · Class II · 21 CFR 872.3930
UDILibrary device dossier · generated 2026-09-11 · 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)
2019-09
0
2
2019-10
0
1
2019-12
0
1.33
2020-05
0
1
2021-03
0
1
2022-01
0
9
2022-04
0
5.5
2022-10
0
2
2023-02
0
2
2024-03
0
2
2024-04
0
2
2024-08
0
12
2024-10
0
3
2025-04
0
1.5
2025-05
0
1
2025-06
0
2.5
2025-12
0
3.14
2026-02
0
2
2026-03
0
3
2026-05
0
1
This device (reports/month)Average device in NPL (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Geistlich Pharma AG