Is this your brand? Sign in to claim ownership.

HIOSSEN INC.

Last updated September 17, 2026

Information

Country: US
Address: 85 BEN FAIRLESS DR, Fairless Hills, PA, 19030
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3007135442
DUNS Number: —

Catalogue (3217)

Page 48 of 65

Device	Model / Reference	Registries	Class	Status
ET Transfer Abutment Set	ETTA6430NCWH	FDA UDI	Class II	Active
EM Provisional	EMT25104	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA603SNW	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA5630P	FDA UDI	Class II	Active
Bite Impression Coping (Mini)	ETBICM4630	FDA UDI	Class I	Active
ET IV Fixture SA Ultra-Wide Pre-Mounted	AET4R7010S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4517SHW	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4640	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICM4421HC	FDA UDI	Class I	Active
ET III Fixture NH Regular Pre-Mounted	AET3R4508B	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS4011CA	FDA UDI	Class I	Active
HG III Fixture RBM Regular No Mount	CHG3S5008R	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7025SHW	FDA UDI	Class II	Active
Et Pick-Up Guide Pin	ETFPG00ML	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4037MP	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI7011	FDA UDI	Class I	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S4010R	FDA UDI	Class II	Active
ET Rigid Burn-out Cylinder	ETRP500SC	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA5670CWH	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC461	FDA UDI	Class I	Active
ET Rigid Burn-out Cylinder	ETRBC50SS	FDA UDI	Class I	Active
ET III NH Ultra-Wide Fixture Pre-Mount	AET3R6006B	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD3015S20	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S4513S	FDA UDI	Class II	Active
EK Healing Abutment	EKHA506	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S3008S	FDA UDI	Class II	Active
Et Stud Abutment	ETSA3530C	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4551H	FDA UDI	Class I	Active
HG II Ultra-Wide Fixture RBM Pre-Mounted	AHG2S6010R	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA14ANRHW	FDA UDI	Class II	Active
ET Gold Cast Abutment SET	ETGA4010BCWH	FDA UDI	Class II	Active
Hiossen Ti Abutment Laboratory Waxing Screw	ETABSMW	FDA UDI	Class I	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R5013S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4027MNW	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4511MH	FDA UDI	Class I	Active
Ek Fixture Transfer Impression Coping	EKTI4511N	FDA UDI	Class I	Active
Et Rigid Impression Coping	ETRIC5004S	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA6770CWH	FDA UDI	Class II	Active
ET IV Fixture SA Regular Pre-Mounted	AET4R5007S	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4430HC	FDA UDI	Class I	Active
ET Angled Abutment(N) With EG Screw	ETAGA432MNW	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4611CP	FDA UDI	Class II	Active
Ek Angled Abutment_b	EKAA4520BTH	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture RBM Pre-Mounted	AHG2S6013R	FDA UDI	Class II	Active
ET Angled Abutment	ETAA4520AC	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETFPI6015SN	FDA UDI	Class I	Active
EK Freeform ST Abutment 5.0(3.0), Non-hex	EKFA5030NTH	FDA UDI	Class II	Active
Bite Impression Coping Driver	ETOICDM	FDA UDI	Class I	Active
O-ring Retainer Cap	ETRCS02C	FDA UDI	Class I	Active
ET IV NH Fixture Pre-Mounted	AET4R5007B	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 27, 2025	Z-1271-2025	—	open, classified	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
Jan 27, 2025	Z-1275-2025	—	open, classified	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
Jan 27, 2025	Z-1273-2025	—	open, classified	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
Jan 27, 2025	Z-1274-2025	—	open, classified	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
Jan 27, 2025	Z-1276-2025	—	open, classified	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
Jan 27, 2025	Z-1272-2025	—	open, classified	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