ET Multi Abutment

GUDID 00810125995583

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: 00810125995583
• NIH Device Record Key: 309b9eee-2283-4cde-b5b0-54cf1d26992b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET Multi Abutment
• Version Model Number: ETMA5020CP
• 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	00810125995583 [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 Multi Abutment]

• 00810019241543: ETMTA505R
• 00810019241536: ETMTA504R
• 00810019241529: ETMTA503R
• 00810019241512: ETMTA502R
• 00810019241505: ETMTA501R
• 00810019241499: ETMTA505M
• 00810019241482: ETMTA504M
• 00810019241475: ETMTA503M
• 00810019241468: ETMTA502M
• 00810019241451: ETMTA501M
• 00810125995613: ETMA5050CP
• 00810125995606: ETMA5040CP
• 00810125995590: ETMA5030CP
• 00810125995583: ETMA5020CP
• 00810125995576: ETMA5010CP
• 00810125995569: ETMA5050MCP
• 00810125995552: ETMA5040MCP
• 00810125995545: ETMA5030MCP
• 00810125995521: ETMA5010MCP