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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 38 of 65

Device	Model / Reference	Registries	Class	Status
ET Healing Abutment	ETHLA7003R	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R5013S	FDA UDI	Class II	Active
Em Sa Implant (narrow Ridge)	EMN3008S40	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6710TH	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFA7015CWH	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIS4014C	FDA UDI	Class I	Active
EK cover screw Middle	EKCS35M	FDA UDI	Class II	Active
ET Angled Abutment Set	ETAA4540MBCWH	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture	CHG2S6008R	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S7006S	FDA UDI	Class II	Unknown
O-ring Retainer	ETRS01C	FDA UDI	Class I	Active
ET Multi Abutment	ETMA5010MCP	FDA UDI	Class II	Active
Et Bite Index	ETBIS5512SC	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA10ANMHW	FDA UDI	Class II	Active
ET II Fixture SA Regular Pre-Mounted	AET2R4511S	FDA UDI	Class II	Active
ET3 D5.5 NH Pre-mounted	AET3R5510B	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI5016N	FDA UDI	Class I	Active
Ek Rigid Abutment	EKRA7620P	FDA UDI	Class II	Active
Esthetic-low Temporary Abutment	ETMTR100TH	FDA UDI	Class I	Active
ET III Fixture BA Regular Pre-Mounted	AET3R4011B	FDA UDI	Class II	Active
ET II Fixture SA Regular No-Mounted	CET2R5015S	FDA UDI	Class II	Active
ET IV NH Fixture Pre-Mounted	AET4R5010B	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4621CP	FDA UDI	Class II	Active
Bite Impression Coping (Mini)	ETBICM4631	FDA UDI	Class I	Active
Em Sa Implant (narrow Ridge)	EMN2510S25	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S4008S	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA5430TH	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4024MP	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4650P	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S5011B	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4732NTH	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S3011S	FDA UDI	Class II	Active
Bite Impression Coping	ETBICR4431	FDA UDI	Class I	Active
Metal sleeve Regular	HOGSCR70S	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA10ARRHW	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S4513B	FDA UDI	Class II	Active
Et Bite Index	ETBIM4512SC	FDA UDI	Class I	Active
ET Digital Lab Analog Regular	ETDLA400	FDA UDI	Class I	Active
ET Rigid Abutment SET	ETRA6710CP	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA601SNW	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA6024SNW	FDA UDI	Class II	Active
Et Pick-Up Guide Pin	ETPGPR100C	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA4015SP	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4761NCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4741NCWH	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIS5011NC	FDA UDI	Class I	Active
ET3 D5.5 SA No mount	CET3R5506S	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR4650HC	FDA UDI	Class I	Active
HG III Fixture Mini RBM No Mount	CHG3M3515R	FDA UDI	Class II	Active
Ek Angled Abutment_a	EKAA5040ATH	FDA UDI	Class II	Active

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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