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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 45 of 65

Device	Model / Reference	Registries	Class	Status
ET Healing Abutment	ETHLA4504M	FDA UDI	Class II	Active
HM Implant Denture	HMD2510R02	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4721CP	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA6740P	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4561CNT	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4577MHW	FDA UDI	Class II	Active
ET III Fixture SA Regular [ Implant Only]	ET3R4007S	FDA UDI	Class II	Active
Metal sleeve Regular	HOGSCR50S	FDA UDI	Class I	Active
HG III Ultra-Wide Fixture RBM Pre-Mounted	AHG3S7010R	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA6420TH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4451CP	FDA UDI	Class II	Active
Ek Multi Angled Abutment	EK17MA4840TH	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA4441P	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI5014SN	FDA UDI	Class I	Active
ET Esthetic-low Pick-Up Impression Coping Guide Pin	ETGP200C	FDA UDI	Class I	Active
Fixture Lab Analog	ETFLAM	FDA UDI	Class I	Active
Em Sa Implant (narrow Ridge)	EMN2513S25	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI7014SH	FDA UDI	Class I	Active
ET Healing Abutment	ETHLA4503R	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA4430CP	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5074SNW	FDA UDI	Class II	Active
HG II Fixture RBM Regular No Mount	CHG2S4010R	FDA UDI	Class II	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S5010R	FDA UDI	Class II	Active
EK Freeform ST Abutment 7.0(1.5), Non-hex	EKFA7015NTH	FDA UDI	Class II	Active
ET Esthetic-low Pick-Up Impression Coping	ETMSR100C	FDA UDI	Class I	Active
Hiossen	AET3M3013S	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4025MP	FDA UDI	Class II	Active
ET III Fixture NH Mini Pre-Mounted	AET3M3511B	FDA UDI	Class II	Active
Hiossen EbonyGold Abutment Screw	ETABSS	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4525SHW	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S4010B	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture Pre-Mount	AET3R7011B	FDA UDI	Class II	Active
ET Angled Abutment(N) With EG Screw	ETAGA434MNW	FDA UDI	Class II	Active
Hiossen Ti Abutment Screw	ETABSST	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S3013B	FDA UDI	Class II	Active
HG III Fixture RBM Regular No Mount	CHG3S4515R	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA6004S	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4541CHT	FDA UDI	Class II	Active
ET IV NH Ultra-Wide Fixture No mount	CET4R6007B	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S7007B	FDA UDI	Class II	Unknown
Ek Rigid Abutment	EKRA4740P	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA6025SP	FDA UDI	Class II	Active
Et Rigid Protect Cap	ETRPC441C	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA6460CWH	FDA UDI	Class II	Active
Et Bite Index	ETBIM4506SC	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA4612NCWH	FDA UDI	Class II	Active
Sm3	SM3 120V OPT	FDA UDI	Class I	Active
ET Rigid Abutment	ETRGA6044SP	FDA UDI	Class II	Active
Et Bite Index	ETBIS5510SC	FDA UDI	Class I	Active
ET Healing Abutment	ETHLA4505M	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