Facility

Hiossen, Inc.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3031162123
Establishment type	Manufacture Medical Device
Location	6940 Beach Blvd Buena Park, CA, US 90621
Registration status	Active · expires 2026
Parent company	Hiossen Inc. (owner-operator 10026425)
Brand names	EK Digital Abutments

Activity by year

Recalls (2)

Devices registered here (1)

Abutment, Implant, Dental, Endosseous
Product code NHA (opens in a new tab) · Class II · Dental · 21 CFR 872.3630

Recalls & enforcement

Class IIOngoing2025-01-27
Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version
Class IIOngoing2023-04-06
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

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Hiossen, Inc. (FEI 3031162123) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3031162123-hiossen-inc/

Not open yet

Alerts for Hiossen, Inc.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.