Chrysalis Intelligence · Sponsors · Ebi, Inc.

Ebi, Inc.

Gyeongsan-Si, KR · 1 510(k) clearances · 4 recalls

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Total clearances
1
2020-01-22 → 2020-01-22
Last 12 months
0
Product codes
1
Most recent
2020-01-22
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DZE Implant, Endosseous, Root-Form Class II Dental 1 2020-01-22
Safety

Recalls (4)

Class I (serious)
0
Risk of injury / death
Total recalls
4
Currently ongoing
4
Most recent
2024-03-22
DateSeverityStatusRecall # ProductCodeReason
2024-03-22 Class II Ongoing Z-1619-2024 48" Lead Wires, Replacement Part Number: 1067724-4 — Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to…
2024-03-22 Class II Ongoing Z-1618-2024 20" Lead Wires, Replacement Part Number: 1067724-2 — Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to…
2024-03-22 Class II Ongoing Z-1617-2024 Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acqui… — Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to…
2024-03-22 Class II Ongoing Z-1616-2024 Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion ac… — Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2020-01-22 K190837 Internal Hex Implant System DZE Class II Dental
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence