Magic Abutcoping (Pick-up type)
Model OSH6526PA · InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) · DI 08800039306096
DZE — Implant, Endosseous, Root-Form · Class II · 21 CFR 872.3640
NHA — Abutment, Implant, Dental, Endosseous · Class II · 21 CFR 872.3630
UDILibrary device dossier · generated 2026-09-12 · 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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.01 |
| 2019-02 | 0 | 5.49 |
| 2019-03 | 0 | 4.3 |
| 2019-04 | 0 | 4.33 |
| 2019-05 | 0 | 4.18 |
| 2019-06 | 0 | 7.51 |
| 2019-07 | 0 | 6.34 |
| 2019-08 | 0 | 5.63 |
| 2019-09 | 0 | 100.93 |
| 2019-10 | 0 | 19.72 |
| 2019-11 | 0 | 16.02 |
| 2019-12 | 0 | 30.59 |
| 2020-01 | 0 | 21.17 |
| 2020-02 | 0 | 20.54 |
| 2020-03 | 0 | 27.01 |
| 2020-04 | 0 | 11.93 |
| 2020-05 | 0 | 16.48 |
| 2020-06 | 0 | 19.75 |
| 2020-07 | 0 | 20.68 |
| 2020-08 | 0 | 21.28 |
| 2020-09 | 0 | 21.13 |
| 2020-10 | 0 | 24.8 |
| 2020-11 | 0 | 25.63 |
| 2020-12 | 0 | 23.63 |
| 2021-01 | 0 | 25.28 |
| 2021-02 | 0 | 22.89 |
| 2021-03 | 0 | 26.45 |
| 2021-04 | 0 | 27.19 |
| 2021-05 | 0 | 26.5 |
| 2021-06 | 0 | 25.58 |
| 2021-07 | 0 | 26.43 |
| 2021-08 | 0 | 25.61 |
| 2021-09 | 0 | 26.47 |
| 2021-10 | 0 | 13.31 |
| 2021-11 | 0 | 37.21 |
| 2021-12 | 0 | 40.7 |
| 2022-01 | 0 | 37.65 |
| 2022-02 | 0 | 34.29 |
| 2022-03 | 0 | 36.64 |
| 2022-04 | 0 | 34.93 |
| 2022-05 | 0 | 36.93 |
| 2022-06 | 0 | 36.67 |
| 2022-07 | 0 | 35.22 |
| 2022-08 | 0 | 37.44 |
| 2022-09 | 0 | 36.46 |
| 2022-10 | 0 | 41.95 |
| 2022-11 | 0 | 39.22 |
| 2022-12 | 0 | 41.64 |
| 2023-01 | 0 | 34.17 |
| 2023-02 | 0 | 35.39 |
| 2023-03 | 0 | 41.17 |
| 2023-04 | 0 | 37.95 |
| 2023-05 | 0 | 41.21 |
| 2023-06 | 0 | 45.7 |
| 2023-07 | 0 | 38.89 |
| 2023-08 | 0 | 32.69 |
| 2023-09 | 0 | 31.32 |
| 2023-10 | 0 | 33.34 |
| 2023-11 | 0 | 36.66 |
| 2023-12 | 0 | 34.38 |
| 2024-01 | 0 | 33.8 |
| 2024-02 | 0 | 34.37 |
| 2024-03 | 0 | 33.68 |
| 2024-04 | 0 | 37.09 |
| 2024-05 | 0 | 34.44 |
| 2024-06 | 0 | 32.76 |
| 2024-07 | 0 | 32.47 |
| 2024-08 | 0 | 31.25 |
| 2024-09 | 0 | 36.52 |
| 2024-10 | 0 | 36.4 |
| 2024-11 | 0 | 30.79 |
| 2024-12 | 0 | 26.03 |
| 2025-01 | 0 | 24.15 |
| 2025-02 | 0 | 23.04 |
| 2025-03 | 0 | 25.37 |
| 2025-04 | 0 | 14.35 |
| 2025-05 | 0 | 10.8 |
| 2025-06 | 0 | 50.67 |
| 2025-07 | 0 | 38.09 |
| 2025-08 | 0 | 31.08 |
| 2025-09 | 0 | 24.7 |
| 2025-10 | 0 | 22.93 |
| 2025-11 | 0 | 25.78 |
| 2025-12 | 0 | 29.57 |
| 2026-01 | 0 | 26.36 |
| 2026-02 | 0 | 26.86 |
| 2026-03 | 0 | 26.41 |
| 2026-04 | 0 | 25.29 |
| 2026-05 | 0 | 26 |
| 2026-06 | 0 | 27.07 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K153350 — cites (transitively): K111120 (d1), K123755 (d1), K140507 (d1), K140806 (d1), K090825 (d2), K093321 (d2), K101096 (d2), K071638 (d3), K073268 (d3), K080396 (d3), K093352 (d3) — cited as predicate by K162099, K173120, K182448, K192197, K202418, K202479, K203344, K223924
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Nothing in the loaded window.