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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 26 of 65

Device	Model / Reference	Registries	Class	Status
ET Pre-milled Abutment	ETPMA14MXRNW	FDA UDI	Class II	Active
ET Angled Abutment_B With EG Screw	ETAGA604SBW	FDA UDI	Class II	Active
ET Digital Lab Analog D3.2	ETDLA300	FDA UDI	Class I	Active
EK Hybrid Zirconia Abutment	EKHZ4563CHT	FDA UDI	Class II	Active
EK Pre-milled Abutment	EKPMA14CAHT	FDA UDI	Class II	Active
HG II Fixture RBM Regular No Mount	CHG2S4511R	FDA UDI	Class II	Active
Et Stud Abutment	ETSA3510C	FDA UDI	Class II	Active
EK Bite Impression Coping	EKBIC4650H	FDA UDI	Class I	Active
EK Bite Impression Coping	EKBIC5620H	FDA UDI	Class I	Active
HS II Fixture Mini RBM Pre-Mounted	AHS2M3513R28	FDA UDI	Class II	Active
Esthetic-low Pick-Up Impression Coping	ETMSW100	FDA UDI	Class I	Active
Em Sa Implant (narrow Ridge)	EMN3013S25	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA5650P	FDA UDI	Class II	Active
EK Transfer Abutment	EKTA4722NTH	FDA UDI	Class II	Active
ET II Fixture SA Mini Pre-Mounted	AET2M3511S	FDA UDI	Class II	Active
Ek Rigid Abutment	EKRA5620P	FDA UDI	Class II	Active
ET FIXTURE PICK-UP IMPRESSION COPING Regular Non-Hex	ETFTI5017SN	FDA UDI	Class I	Active
ET II Fixture SA Regular Pre-Mounted	AET2R4518S	FDA UDI	Class II	Active
ET III Fixture NH Regular [ Implant Only ]	ET3R4515B	FDA UDI	Class II	Active
A-graft®[Bone grafting material, Animal source]	HAS025LV	FDA UDI	Class II	Active
HG II Fixture Regular RBM Pre-Mounted	AHG2S4010R	FDA UDI	Class II	Active
ET II Fixture SA Regular Pre-Mounted	AET2R4508S	FDA UDI	Class II	Active
ET Transfer Abutment Set	ETTAS4731CWH	FDA UDI	Class II	Active
EK III NH Fixture No Mount	CEK3S3010B	FDA UDI	Class II	Unknown
ET Transfer Abutment Set	ETTA5470CWH	FDA UDI	Class II	Active
ET Rigid Abutment SET	ETRA6640CP	FDA UDI	Class II	Active
Et Ziocera Abutment	ETZCA653SHW	FDA UDI	Class II	Active
ET Rigid Abutment	ETRGA4557MP	FDA UDI	Class II	Active
EK Healing Abutment	EKHA509	FDA UDI	Class II	Active
Ek Temporary Abutment	EKTTA4530TH	FDA UDI	Class II	Active
Et Rigid Impression Coping	ETRIC640SC	FDA UDI	Class I	Active
Em Sa Implant (denture)	EMD2011S20	FDA UDI	Class II	Active
ET FIXTURE PICK-UP IMPRESSION COPING Regular Hex	ETFTI5020SH	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA5047SHW	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10CARHW	FDA UDI	Class II	Active
Martfit Bone Reduction Guide 10 Holes	ETSGBR10	FDA UDI	Class I	Active
ET Bite Impression Coping	ETBICR4431HC	FDA UDI	Class I	Active
ET cover screw Regular, Long	ETCS40L-G	FDA UDI	Class II	Active
ET Pre-milled Abutment	ETPMA10ANMNW	FDA UDI	Class II	Active
EK Healing Abutment	EKHA503	FDA UDI	Class II	Active
Et Fixture Transfer Impression Coping	ETTIM4514NC	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICR5550H	FDA UDI	Class I	Active
ET Bite Impression Coping Hex	ETBICM4540H	FDA UDI	Class I	Active
EK Transfer Abutment	EKTA5630NTH	FDA UDI	Class II	Active
ET Bite Impression Coping Hex	ETBICM4441H	FDA UDI	Class I	Active
ET Transfer Abutment	ETTA4567MHW	FDA UDI	Class II	Active
Em Sa Implant (denture)	EMD2008S40	FDA UDI	Class II	Active
Met+C2:C36al sleeve narrow	HOGSCN35S	FDA UDI	Class I	Active
Et Rigid Protect Cap	ETRPC470C	FDA UDI	Class I	Active
ET III Fixture BA Regular Pre-Mounted	AET3R5013B	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