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Model AJ16 · Guangzhou Ajax Medical Equipment Co., Ltd. · DI 06971608310041
EIA — Unit, Operative Dental · Class I · 21 CFR 872.6640
UDILibrary device dossier · generated 2026-09-06 · 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
2.29
2019-04
0
1.83
2019-06
0
1.25
2019-07
0
2
2019-10
0
2
2020-01
0
1.86
2020-04
0
1.71
2020-07
0
1.83
2020-10
0
1.43
2020-12
0
1
2021-01
0
2.2
2021-04
0
2
2021-07
0
1.5
2021-10
0
2
2022-01
0
1.75
2022-04
0
2
2022-07
0
1.83
2022-08
0
1
2022-09
0
1
2022-10
0
2.14
2023-01
0
1.6
2023-02
0
1.5
2023-04
0
1.75
2023-05
0
2
2023-06
0
1
2023-07
0
2
2023-09
0
1
2023-10
0
2.2
2024-01
0
1.5
2024-02
0
2
2024-03
0
1
2024-04
0
2.4
2024-07
0
2.83
2024-10
0
1.8
2025-01
0
2.17
2025-04
0
2.33
2025-07
0
2.67
2025-10
0
2
2025-12
0
1
2026-01
0
2
2026-04
0
1.5
This device (reports/month)Average device in EIA (reports/device/month)
Regulatory clearances
K132245 SESE 2014-09-05 (k number procode)
Manufacturer compliance record — Guangzhou Ajax Medical Equipment Co., Ltd.