ET STUD ABUTMENT

GUDID 00810125995422

HIOSSEN, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 00810125995422
• NIH Device Record Key: da0b2d9c-2e9e-44e9-aecd-92656e9861be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET STUD ABUTMENT
• Version Model Number: ETSAM3530C
• Company DUNS: 796083090
• Company Name: HIOSSEN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810125995422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222636

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-01
• Device Publish Date: 2024-06-21

On-Brand Devices [ET STUD ABUTMENT ]

• 00810125995514: ETSA3560C
• 00810125995507: ETSA3550C
• 00810125995491: ETSA3540C
• 00810125995484: ETSA3530C
• 00810125995477: ETSA3520C
• 00810125995460: ETSA3510C
• 00810125995453: ETSAM3560C
• 00810125995446: ETSAM3550C
• 00810125995439: ETSAM3540C
• 00810125995422: ETSAM3530C
• 00810125995415: ETSAM3520C
• 00810125995408: ETSAM3510C