Chrysalis Intelligence · Sponsors · Hiossen, Inc.

Hiossen, Inc.

Fariless Hills, PA, US · 7 510(k) clearances · 7 recalls

Total clearances
7
2022-01-07 → 2026-05-14
Last 12 months
2
Product codes
2
Most recent
2026-05-14
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NHA Abutment, Implant, Dental, Endosseous Class II Dental 5 2026-05-14
DZE Implant, Endosseous, Root-Form Class II Dental 2 2024-09-13
Safety

Recalls (7)

Class I (serious)
0
Risk of injury / death
Total recalls
7
Currently ongoing
7
Most recent
2025-01-27
DateSeverityStatusRecall # ProductCodeReason
2025-01-27 Class II Ongoing Z-1276-2025 Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implan… Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version…
2025-01-27 Class II Ongoing Z-1275-2025 ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prostheti… Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version…
2025-01-27 Class II Ongoing Z-1274-2025 Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implan… Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version…
2025-01-27 Class II Ongoing Z-1273-2025 ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthet… Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version…
2025-01-27 Class II Ongoing Z-1272-2025 ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthet… Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version…
2025-01-27 Class II Ongoing Z-1271-2025 ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthet… Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version…
2023-04-06 Class II Ongoing Z-1604-2023 ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm
Filings

All 510(k) clearances (7)

Date K-number Device Code Class Specialty
2026-05-14 K253372 ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments NHA Class II Dental
2026-01-29 K251427 EK MULTI ANGLED 30 ABUTMENT NHA Class II Dental
2025-01-08 K241003 HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) NHA Class II Dental
2024-09-13 K240232 EK D3.3 and Ultra Wide Implants DZE Class II Dental
2024-05-29 K233389 EK Digital Abutments NHA Class II Dental
2023-04-28 K222636 ET Abutment System NHA Class II Dental
2022-01-07 K203360 EK Implants and Abutments System DZE Class II Dental