Facility

HIOSSEN INC.

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

Key facts

2recalls · worst Class II

1inspections · worst NAI

—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)	3010185635
Establishment type	Repack or Relabel Medical Device
Location	50 Maple Street Norwood, NJ, US 07648
Registration status	Active · expires 2026
Parent company	Hiossen Inc. (owner-operator 10026425)
Brand names	SM3

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (3)

Controller, Foot, Handpiece And Cord
Product code EBW (opens in a new tab) · Class I · Dental · 21 CFR 872.4200
Handpiece, Rotary Bone Cutting
Product code KMW (opens in a new tab) · Class II · Dental · 21 CFR 872.4120
Handpiece, Contra- And Right-Angle Attachment, Dental
Product code EGS (opens in a new tab) · Class I · Dental · 21 CFR 872.4200

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

FDA inspections (1)

NAI2017-04-24
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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 3010185635) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010185635-hiossen-inc/

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