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)	3017450159
Establishment type	Manufacture Medical Device
Location	56-58A East Bridge Street Morrisville, PA, US 19067
Registration status	Active · expires 2026
Parent company	Hiossen Inc. (owner-operator 10026425)
Brand names	Rigid Lab Analog; Convertible Pick-Up Impression Coping; Bite Impression Coping Driver; O-ring Lab Analog; Fixture Pick-up Impression Coping; 3D LAB ANALOG; ET Fixture Lab Analog; ET Fixture Transfer Impression Coping; ONE GUIDE SURGICAL TEMPLATE; Hiossen Ti Abutment Screw; Esthetic Low Polishing Protector; ET Bite Index

Activity by year

Recalls (2)

Devices registered here (1)

Accessories, Implant, Dental, Endosseous
Product code NDP (opens in a new tab) · Class I · Dental · 21 CFR 872.3980

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 3017450159) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3017450159-hiossen-inc/

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