Print-ready dossier — use your browser's print dialog to save as PDF.
Advanced Dental System
Model 90-2115D · ASI MEDICAL, INC. · DI 00850309007152
DZI — Drill, Bone, Powered · Class II · 21 CFR 872.4120
EBZ — Activator, Ultraviolet, For Polymerization · Class II · 21 CFR 872.6070
EFA — Handpiece, Belt And/Or Gear Driven, Dental · Class I · 21 CFR 872.4200
EIA — Unit, Operative Dental · Class I · 21 CFR 872.6640
EKR — Plugger, Root Canal, Endodontic · Class I · 21 CFR 872.4565
EKX — Handpiece, Direct Drive, Ac-Powered · Class I · 21 CFR 872.4200
ELC — Scaler, Ultrasonic · Class II · 21 CFR 872.4850
LQY — Locator, Root Apex
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)
2019-01
0
2.18
2019-02
0
2.2
2019-03
0
2.2
2019-04
0
1.82
2019-05
0
1.84
2019-06
0
2.47
2019-07
0
2.29
2019-08
0
3.17
2019-09
0
2.5
2019-10
0
2.06
2019-11
0
1.78
2019-12
0
2.86
2020-01
0
2.4
2020-02
0
2.6
2020-03
0
2.73
2020-04
0
1.74
2020-05
0
2.67
2020-06
0
3.2
2020-07
0
2.11
2020-08
0
1.88
2020-09
0
3.45
2020-10
0
2.38
2020-11
0
2.77
2020-12
0
3.29
2021-01
0
2.36
2021-02
0
2.13
2021-03
0
2.06
2021-04
0
2.22
2021-05
0
2
2021-06
0
3.77
2021-07
0
2.73
2021-08
0
3
2021-09
0
1.85
2021-10
0
1.7
2021-11
0
3.8
2021-12
0
2.5
2022-01
0
3.25
2022-02
0
2.22
2022-03
0
2.29
2022-04
0
1.8
2022-05
0
2.06
2022-06
0
2.6
2022-07
0
2.5
2022-08
0
2.5
2022-09
0
4.42
2022-10
0
2.17
2022-11
0
2.5
2022-12
0
3.18
2023-01
0
2.5
2023-02
0
2.75
2023-03
0
2.5
2023-04
0
2.29
2023-05
0
2.25
2023-06
0
2.41
2023-07
0
2.33
2023-08
0
2.47
2023-09
0
1.94
2023-10
0
2.27
2023-11
0
1.86
2023-12
0
2.06
2024-01
0
2.8
2024-02
0
1.89
2024-03
0
2.14
2024-04
0
2.16
2024-05
0
2.52
2024-06
0
2.55
2024-07
0
2.55
2024-08
0
2.5
2024-09
0
2.44
2024-10
0
2.27
2024-11
0
2.33
2024-12
0
2.31
2025-01
0
2.5
2025-02
0
2.07
2025-03
0
2.42
2025-04
0
2
2025-05
0
2.63
2025-06
0
2.35
2025-07
0
1.76
2025-08
0
2.25
2025-09
0
2.62
2025-10
0
2.18
2025-11
0
2.2
2025-12
0
2.12
2026-01
0
1.87
2026-02
0
1.64
2026-03
0
2.29
2026-04
0
2.4
2026-05
0
2.21
2026-06
0
2.94
This device (reports/month)Average device in DZI, EBZ, EFA, EIA, EKR, EKX, ELC, LQY (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — ASI MEDICAL, INC.