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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 42 of 65

Device	Model / Reference	Registries	Class	Status
ET Rigid Abutment SET	ETRA4640CP	FDA UDI	Class II	Active
ET Angled Abutment_B With EG Screw	ETAA4040MNCWH	FDA UDI	Class II	Active
ET Angled Abutment	ETAA4520NC	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI4511	FDA UDI	Class I	Active
EK Pre-milled Abutment	EKPMA10ZKHT	FDA UDI	Class II	Active
Et Stud Abutment Set	ETSAO353M	FDA UDI	Class II	Active
ET IV NH Fixture No mount	CET4R5011B	FDA UDI	Class II	Active
Esthetic-low Transfer Impression Coping	ETMTTW100	FDA UDI	Class I	Active
Et Rigid Retraction Cap	ETRRC441	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICR4521HC	FDA UDI	Class I	Active
Bite Impression Coping	ETBICR5640	FDA UDI	Class I	Active
Et Fixture Pick-Up Impression Coping	ETPIS4515CA	FDA UDI	Class I	Active
EK III NH Fixture No Mount	CEK3S5013B	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5074SHW	FDA UDI	Class II	Active
HS II Fixture Mini RBM Pre-Mounted	AHS2M3508R18	FDA UDI	Class II	Active
ET III SA Ultra-Wide Fixture Pre-Mounted	AET3R6010S	FDA UDI	Class II	Active
Esthetic-low Pick-Up Impression Coping Guide Pin	ETGP200	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA7620NTH	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4034SP	FDA UDI	Class II	Active
Smartfit Final Hybrid Denture - 10	FNLHYD010	FDA UDI	Class I	Active
Et Ziocera Abutment	ETZCA455SHW	FDA UDI	Class II	Active
Et Bite Index	ETBIS5508SC	FDA UDI	Class I	Active
ET II Fixture SA Regular Pre-Mounted	AET2R5011S	FDA UDI	Class II	Active
ET II Fixture SA Mini Pre-Mounted	AET2M3513S	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4651H	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA10HUMHW	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA6710CWH	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC440	FDA UDI	Class I	Active
Smartfit Final Hybrid Denture - 9	FNLHYD09	FDA UDI	Class I	Active
ET III Fixture BA Regular Pre-Mounted	AET3R5010B	FDA UDI	Class II	Active
Screw-Custom Healing ABT	ETCHABSMT	FDA UDI	Class II	Active
EK Pre-milled Abutment	EKPMA14ZKNT	FDA UDI	Class II	Active
ET II Fixture SA Mini No-Mounted	CET2M3511S	FDA UDI	Class II	Active
Esthetic-low Transfer Impression Coping	ETMTTR100	FDA UDI	Class I	Active
ET III NH Ultra-Wide Fixture No-Mount	CET3R6011B	FDA UDI	Class II	Active
Ek Fixture Pick-Up Impression Coping	EKPI4011	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4611NTH	FDA UDI	Class II	Active
HS II Fixture Mini RBM Pre-Mounted	AHS2M3513R18	FDA UDI	Class II	Active
ET3 D5.5 NH Pre-mounted	AET3R5507B	FDA UDI	Class II	Active
ET SmartFit Abutment	ETCMASH	FDA UDI	Class II	Active
HM Implant Narrow Ridge	HMN3013R03	FDA UDI	Class II	Active
ET IV Fixture SA Regular No Mount	CET4R5008S	FDA UDI	Class II	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S5011R	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS7011NCA	FDA UDI	Class I	Active
ET Angled Abutment	ETAA4540MNC	FDA UDI	Class II	Active
Ek Bite Index	EKBI4512S	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4742NTH	FDA UDI	Class II	Active
Et Bite Index	ETBIM4508S	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA4632TH	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD3013S40	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