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EK III NH Fixture Pre-Mounted

Model AEK3S6008B · HIOSSEN, INC. · DI 00810126040077

DZE — Implant, Endosseous, Root-Form · Class II · 21 CFR 872.3640

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.

2551761022019-01: 0 reports for this device; peer average 4.02/device2019-02: 0 reports for this device; peer average 5.49/device2019-03: 0 reports for this device; peer average 4.31/device2019-04: 0 reports for this device; peer average 4.35/device2019-05: 0 reports for this device; peer average 4.17/device2019-06: 0 reports for this device; peer average 7.53/device2019-07: 0 reports for this device; peer average 6.39/device2019-08: 0 reports for this device; peer average 5.67/device2019-09: 0 reports for this device; peer average 101.74/device2019-10: 0 reports for this device; peer average 19.81/device2019-11: 0 reports for this device; peer average 16.08/device2019-12: 0 reports for this device; peer average 30.69/device2020-01: 0 reports for this device; peer average 21.27/device2020-02: 0 reports for this device; peer average 20.62/device2020-03: 0 reports for this device; peer average 27.38/device2020-04: 0 reports for this device; peer average 11.97/device2020-05: 0 reports for this device; peer average 16.48/device2020-06: 0 reports for this device; peer average 19.79/device2020-07: 0 reports for this device; peer average 20.77/device2020-08: 0 reports for this device; peer average 21.31/device2020-09: 0 reports for this device; peer average 21.29/device2020-10: 0 reports for this device; peer average 24.87/device2020-11: 0 reports for this device; peer average 25.78/device2020-12: 0 reports for this device; peer average 23.76/device2021-01: 0 reports for this device; peer average 25.39/device2021-02: 0 reports for this device; peer average 23.01/device2021-03: 0 reports for this device; peer average 26.58/device2021-04: 0 reports for this device; peer average 27.25/device2021-05: 0 reports for this device; peer average 26.71/device2021-06: 0 reports for this device; peer average 25.72/device2021-07: 0 reports for this device; peer average 26.62/device2021-08: 0 reports for this device; peer average 25.87/device2021-09: 0 reports for this device; peer average 26.57/device2021-10: 0 reports for this device; peer average 13.4/device2021-11: 0 reports for this device; peer average 37.66/device2021-12: 0 reports for this device; peer average 40.89/device2022-01: 0 reports for this device; peer average 37.75/device2022-02: 0 reports for this device; peer average 34.42/device2022-03: 0 reports for this device; peer average 36.79/device2022-04: 0 reports for this device; peer average 35.22/device2022-05: 0 reports for this device; peer average 37.22/device2022-06: 0 reports for this device; peer average 36.79/device2022-07: 0 reports for this device; peer average 35.39/device2022-08: 0 reports for this device; peer average 37.6/device2022-09: 0 reports for this device; peer average 36.7/device2022-10: 0 reports for this device; peer average 42.21/device2022-11: 0 reports for this device; peer average 39.36/device2022-12: 0 reports for this device; peer average 41.85/device2023-01: 0 reports for this device; peer average 34.77/device2023-02: 0 reports for this device; peer average 35.66/device2023-03: 0 reports for this device; peer average 41.37/device2023-04: 0 reports for this device; peer average 38.17/device2023-05: 0 reports for this device; peer average 41.87/device2023-06: 0 reports for this device; peer average 45.96/device2023-07: 0 reports for this device; peer average 39.31/device2023-08: 0 reports for this device; peer average 33.01/device2023-09: 0 reports for this device; peer average 31.49/device2023-10: 0 reports for this device; peer average 33.43/device2023-11: 0 reports for this device; peer average 36.94/device2023-12: 0 reports for this device; peer average 34.53/device2024-01: 0 reports for this device; peer average 34.21/device2024-02: 0 reports for this device; peer average 34.57/device2024-03: 0 reports for this device; peer average 34.07/device2024-04: 0 reports for this device; peer average 37.37/device2024-05: 0 reports for this device; peer average 34.78/device2024-06: 0 reports for this device; peer average 33.12/device2024-07: 0 reports for this device; peer average 32.62/device2024-08: 0 reports for this device; peer average 31.39/device2024-09: 0 reports for this device; peer average 36.84/device2024-10: 0 reports for this device; peer average 36.67/device2024-11: 0 reports for this device; peer average 30.96/device2024-12: 0 reports for this device; peer average 26.15/device2025-01: 0 reports for this device; peer average 24.35/device2025-02: 0 reports for this device; peer average 23.19/device2025-03: 0 reports for this device; peer average 25.54/device2025-04: 0 reports for this device; peer average 14.63/device2025-05: 0 reports for this device; peer average 10.86/device2025-06: 0 reports for this device; peer average 51.12/device2025-07: 0 reports for this device; peer average 38.65/device2025-08: 0 reports for this device; peer average 31.25/device2025-09: 0 reports for this device; peer average 24.9/device2025-10: 0 reports for this device; peer average 23.31/device2025-11: 0 reports for this device; peer average 25.93/device2025-12: 0 reports for this device; peer average 29.86/device2026-01: 0 reports for this device; peer average 27.04/device2026-02: 0 reports for this device; peer average 27.07/device2026-03: 0 reports for this device; peer average 26.64/device2026-04: 0 reports for this device; peer average 25.99/device2026-05: 0 reports for this device; peer average 26.41/device2026-06: 0 reports for this device; peer average 27.45/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.02
2019-0205.49
2019-0304.31
2019-0404.35
2019-0504.17
2019-0607.53
2019-0706.39
2019-0805.67
2019-090101.74
2019-10019.81
2019-11016.08
2019-12030.69
2020-01021.27
2020-02020.62
2020-03027.38
2020-04011.97
2020-05016.48
2020-06019.79
2020-07020.77
2020-08021.31
2020-09021.29
2020-10024.87
2020-11025.78
2020-12023.76
2021-01025.39
2021-02023.01
2021-03026.58
2021-04027.25
2021-05026.71
2021-06025.72
2021-07026.62
2021-08025.87
2021-09026.57
2021-10013.4
2021-11037.66
2021-12040.89
2022-01037.75
2022-02034.42
2022-03036.79
2022-04035.22
2022-05037.22
2022-06036.79
2022-07035.39
2022-08037.6
2022-09036.7
2022-10042.21
2022-11039.36
2022-12041.85
2023-01034.77
2023-02035.66
2023-03041.37
2023-04038.17
2023-05041.87
2023-06045.96
2023-07039.31
2023-08033.01
2023-09031.49
2023-10033.43
2023-11036.94
2023-12034.53
2024-01034.21
2024-02034.57
2024-03034.07
2024-04037.37
2024-05034.78
2024-06033.12
2024-07032.62
2024-08031.39
2024-09036.84
2024-10036.67
2024-11030.96
2024-12026.15
2025-01024.35
2025-02023.19
2025-03025.54
2025-04014.63
2025-05010.86
2025-06051.12
2025-07038.65
2025-08031.25
2025-09024.9
2025-10023.31
2025-11025.93
2025-12029.86
2026-01027.04
2026-02027.07
2026-03026.64
2026-04025.99
2026-05026.41
2026-06027.45
This device (reports/month)Average device in DZE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K240232 — cites (transitively): K140934 (d1), K151626 (d1), K153332 (d1), K203360 (d1), K063341 (d2), K083633 (d2), K101096 (d2), K103537 (d2), K120847 (d2), K121585 (d2), K123471 (d2), K053088 (d2), K112532 (d2), K123784 (d2), K102436 (d2), K122171 (d2), K110308 (d2), K140507 (d2), K161689 (d2), K182091 (d2), K093352 (d3), K081575 (d3), K093889 (d3), K100245 (d3), K072363 (d3), K073070 (d3), K080387 (d3), K072679 (d3), K091678 (d3), K093027 (d3), K061176 (d3), K083067 (d3), K090237 (d3), K033922 (d3), K033984 (d3), K062129 (d3), K081419 (d3), K083550 (d3), K121131 (d3), K122855 (d3), K983742 (d3), K062051 (d3), K063861 (d3), K081786 (d3), K121995 (d3), K130662 (d3), K062030 (d3), K080594 (d3), K132067 (d3), K150295 (d3), K160519 (d3), K160670 (d3), K070478 (d4), K073465 (d4), K091208 (d4), K003271 (d4), K003552 (d4), K012757 (d4), K123755 (d4), K000100 (d4), K010073 (d4), K020646 (d4), K022562 (d4), K030463 (d4), K041509 (d4), K061410 (d4), K063286 (d4), K071370 (d4), K071638 (d4), K072878 (d4), K073075 (d4), K082639 (d4), K083496 (d4), K093321 (d4), K103089 (d4), K113779 (d4), K120414 (d4), K130222 (d4), K133991 (d4), K143022 (d4), K062509 (d4), K093708 (d4), K100152 (d4), K111421 (d4), K123664 (d4), K132209 (d4), K151324 (d4), K072896 (d4), K073247 (d4), K121843 (d4), K082213 (d5), K073268 (d5), K080396 (d5), K013867 (d5), K032158 (d5), K032448 (d5), K060880 (d5), K062493 (d5), K072642 (d5), K081005 (d5), K081666 (d5), K091756 (d5), K014235 (d5), K060958 (d5), K061629 (d5), K073345 (d5), K980549 (d5), K063779 (d5), K103252 (d5), K072624 (d5), K083805 (d5), K091239 (d5), K101005 (d5), K101849 (d5), K120338 (d5), K974738 (d5), K980698 (d5), K142890 (d5), K070833 (d6), K042658 (d6), K043042 (d6), K061477 (d6), K072856 (d6), K120053 (d6), K120822 (d6), K132219 (d6), K072071 (d7), K052272 (d7), K071548 (d7), K072055 (d7), K072151 (d7), K072569 (d7), K080195 (d7), K082764 (d7), K093113 (d7), K101465 (d7), K113283 (d7), K041236 (d8), K090069 (d8), K080286 (d8), K082545 (d8) — cited as predicate by K251427, K260555

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — HIOSSEN, INC.

  • Warning Letter 2012-10-05 Hiossen Inc.
  • Warning Letter 2012-10-05 Hiossen Inc.
  • VAI 2025-07-23 Hiossen Inc. · 1 citations
  • VAI 2025-07-23 Hiossen Inc. · 1 citations
  • NAI 2017-04-24 Hiossen Inc. · 0 citations
  • NAI 2017-04-24 Hiossen Inc. · 0 citations
  • VAI 2017-04-12 Hiossen Inc. · 2 citations
  • VAI 2017-04-12 Hiossen Inc. · 2 citations
  • VAI 2013-04-18 Hiossen Inc. · 0 citations
  • VAI 2013-04-18 Hiossen Inc. · 0 citations
  • OAI 2012-05-16 Hiossen Inc. · 0 citations
  • OAI 2012-05-16 Hiossen Inc. · 0 citations