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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 50 of 65

Device	Model / Reference	Registries	Class	Status
Et Pick-Up Guide Pin	ETPGPM200LC	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4042ONT	FDA UDI	Class II	Active
Et Bite Index	ETBIS5512S	FDA UDI	Class I	Active
Et Freeform St Abutment	ETFSA403MHW	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S7008S	FDA UDI	Class II	Unknown
EK Healing Abutment	EKHA407	FDA UDI	Class II	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4508R28	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4557SP	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S3008S	FDA UDI	Class II	Unknown
Et Fixture Pick-Up Impression Coping	ETPIS4511NCA	FDA UDI	Class I	Active
ET Angled Abutment	ETAA5040BC	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS4515AC	FDA UDI	Class I	Active
ET Laboratory Screw	ETABSSLC	FDA UDI	Class I	Active
ET Transfer Abutment SET	ETTA4631CWH	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S7010S	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10HURHW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA4622NCWH	FDA UDI	Class II	Active
HG II Ultra-Wide Fixture	CHG2S7010R	FDA UDI	Class II	Active
ET Bite Impression Coping	ETBICR5520HC	FDA UDI	Class I	Active
Hiossen Ti Abutment Laboratory Waxing Screw	ETABSSW	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICR4621HC	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA10CAMNW	FDA UDI	Class II	Active
EK cover screw Short	EKCS35S	FDA UDI	Class II	Active
Em Sa Implant (narrow Ridge)	EMN2515S25	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S4508S	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC471	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4525MHW	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIS4011NC	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4545SHW	FDA UDI	Class II	Active
ET Angled Abutment	ETAA4520MAC	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA4575SNW	FDA UDI	Class II	Active
Et Rigid Lab Analog	ETRLA471C	FDA UDI	Class I	Active
Et Fixture Transfer Impression Coping	ETTIS4511C	FDA UDI	Class I	Active
ET IV Fixture SA Ultra-Wide No Mount	CET4R6010S	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA7410NTH	FDA UDI	Class II	Active
Et Freeform St Abutment	ETFSA703SHW	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S5013S	FDA UDI	Class II	Active
ET Multi Abutment	ETMTA503M	FDA UDI	Class II	Active
Ek Abutment Laboratory Screw	EKABSL	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA5017SNW	FDA UDI	Class II	Active
ET III NH Ultra-Wide Fixture No-Mount	CET3R7006B	FDA UDI	Class II	Active
ET Convertible Protect Cap	ETCHC400CWH	FDA UDI	Class I	Active
HS II Fixture Regular RBM Pre-Mounted	AHS2R4511R28	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4611NCWH	FDA UDI	Class II	Active
Esthetic-low Temporary Abutment	ETMTW200TH	FDA UDI	Class I	Active
EK Freeform ST Abutment 6.0(1.5), Non-hex	EKFA6015NTH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4711CWH	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7054SNW	FDA UDI	Class II	Active
ET II Fixture SA Mini Pre-Mounted	AET2M3515S	FDA UDI	Class II	Active
EK III SA Fixture No Mount	CEK3S4510S	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