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ACTEON
Model AIR N GO EASY WH x 2BUSES · SATELEC · DI 03609820101323
EFB — Handpiece, Air-Powered, Dental · Class I · 21 CFR 872.4200
UDILibrary device dossier · generated 2026-09-07 · 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)
2019-04
0
1
2019-06
0
1
2019-07
0
1
2019-12
0
1
2020-01
0
1
2020-04
0
2
2020-08
0
1
2020-11
0
1
2021-01
0
1.33
2022-01
0
1
2022-03
0
1
2022-04
0
1
2022-05
0
1
2022-06
0
1
2022-07
0
1
2022-08
0
1.67
2022-09
0
2
2022-10
0
1.88
2022-12
0
2
2023-01
0
2
2023-02
0
1.25
2023-03
0
1
2023-04
0
1.75
2023-05
0
1
2023-06
0
1
2023-07
0
1.5
2023-08
0
1.56
2023-09
0
1.13
2023-10
0
1
2023-12
0
1
2024-01
0
1.14
2024-02
0
1.33
2024-03
0
2.33
2024-04
0
1.17
2024-05
0
1.5
2024-06
0
1.67
2024-07
0
1
2024-08
0
1
2024-09
0
1
2024-10
0
1
2024-11
0
1
2024-12
0
1
2025-01
0
1.27
2025-02
0
1
2025-03
0
1
2025-04
0
1
2025-05
0
1.67
2025-06
0
1
2025-07
0
1.7
2025-10
0
1.29
2025-11
0
4
2025-12
0
2.5
2026-01
0
1.25
2026-02
0
1
2026-03
0
1.67
2026-04
0
1.06
2026-05
0
1.33
2026-06
0
1
This device (reports/month)Average device in EFB (reports/device/month)
Regulatory clearances
K110379 SESE 2011-12-08 (k number procode)
Predicate lineage
K110379 — cites (transitively): K022119 (d1), K082791 (d1), K092289 (d1) — cited as predicate by K140684
Lineage extracted from public 510(k) summary text (heuristic).