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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 3 of 65

Device	Model / Reference	Registries	Class	Status
HS II Fixture Regular RBM Pre-Mounted	AHS2R4008R28	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7035SHW	FDA UDI	Class II	Active
ET Quick Temporary Abutment	ETQTA401MHT	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S6008B	FDA UDI	Class II	Unknown
ET II Fixture SA Regular No-Mounted	CET2R4011S	FDA UDI	Class II	Active
HG III Ultra-Wide Fixture RBM Pre-Mounted	AHG3S7013R	FDA UDI	Class II	Active
ET III Fixture SA Mini Pre-Mounted	AET3M3518S	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA14CAMNW	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4020MN	FDA UDI	Class I	Active
EK Pre-milled Abutment	EKPMA14ARHT	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRAS4430CP	FDA UDI	Class II	Active
EK III SA Fixture Pre-Mounted	AEK3S3011S	FDA UDI	Class II	Unknown
EK III SA Fixture Pre-Mounted	AEK3S3510S	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA5075SHW	FDA UDI	Class II	Active
ET Quick Temporary Abutment	ETQTA451RHT	FDA UDI	Class II	Active
Ek Bite Index	EKBI5504S	FDA UDI	Class I	Active
ET Transfer Abutment Set	ETTA4661CWH	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETFTI4014SN	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA5440NTH	FDA UDI	Class II	Active
EK Hybrid Zirconia Abutment	EKHZ4062CNT	FDA UDI	Class II	Active
Et Pick-Up Guide Pin	ETPGPR100LC	FDA UDI	Class I	Active
Et Rigid Protect Cap	ETRPC6005S	FDA UDI	Class I	Active
ET Pre-milled Abutment	ETPMA10MXMNW	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4440H	FDA UDI	Class I	Active
ET Convertible Pick-up Guide Pin	ETCGP500LC	FDA UDI	Class I	Active
EK III NH Fixture Pre-Mounted	AEK3S3508B	FDA UDI	Class II	Active
ET Quick Temporary Abutment	ETQTA451RNT	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4431	FDA UDI	Class I	Active
ET II Fixture SA Regular Pre-Mounted	AET2R4010S	FDA UDI	Class II	Active
Et Fixture Pick-Up Impression Coping	ETPIS4011NAC	FDA UDI	Class I	Active
ET III Fixture SA Regular Pre-Mounted	AET3R5011S	FDA UDI	Class II	Active
ET Angled Abutment	ETAA4040MAC	FDA UDI	Class II	Active
ET Convertible Pick-up Guide Pin	ETCGP400SC	FDA UDI	Class I	Active
Et Fixture Transfer Impression Coping	ETTIM4511C	FDA UDI	Class I	Active
Ek Fixture Pick-Up Impression Coping	EKPI7016N	FDA UDI	Class I	Active
Em Sa Implant (narrow Ridge)	EMN2508S40	FDA UDI	Class II	Active
ET Transfer Abutment	ETTA7024SNW	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD2513S20	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4621NCWH	FDA UDI	Class II	Active
HM Implant Narrow Ridge	HMN2515R03	FDA UDI	Class II	Active
ET III Fixture SA Regular Pre-Mounted	AET3R4007S	FDA UDI	Class II	Active
EK Healing Abutment	EKHA507	FDA UDI	Class II	Active
ET Angled Abutment Set	ETAA5020BCWH	FDA UDI	Class II	Active
Et Freeform St Abutment Set	ETFA7015NCWH	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTA7470CWH	FDA UDI	Class II	Active
A-Oss®	AOSN050SV	FDA UDI	Class II	Unknown
ET Healing Abutment	ETHLA4507M	FDA UDI	Class II	Active
HG III Fixture RBM Regular Pre-Mounted	AHG3S4008R	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA14ANRNW	FDA UDI	Class II	Active
Et Rigid Retraction Cap	ETRRC460	FDA UDI	Class I	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