ET Rigid Abutment SET

GUDID 00810125990175

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: 00810125990175
• NIH Device Record Key: d7270be3-034b-4623-9f4a-73d5232d2431
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET Rigid Abutment SET
• Version Model Number: ETRAS4730CP
• 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: true
• 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	00810125990175 [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: 2024-07-03
• Device Publish Date: 2024-06-25

On-Brand Devices [ET Rigid Abutment SET]

• 00810125990335: ETRAS4611CP
• 00810125990076: ETRAS4420CP
• 00810125990069: ETRA4420CP
• 00810125990052: ETRAS4710CP
• 00810125990045: ETRA4710CP
• 00810125990038: ETRAS4610CP
• 00810125990021: ETRA4610CP
• 00810125990014: ETRAS4410CP
• 00810125990007: ETRA4410CP
• 00810125990564: ETRA4651CP
• 00810125990557: ETRAS4451CP
• 00810125990540: ETRA4451CP
• 00810125990533: ETRAS4741CP
• 00810125990526: ETRA4741CP
• 00810125990519: ETRAS4641CP
• 00810125990502: ETRA4641CP
• 00810125990496: ETRAS4441CP
• 00810125990489: ETRA4441CP
• 00810125990472: ETRAS4731CP
• 00810125990465: ETRA4731CP
• 00810125990458: ETRAS4631CP
• 00810125990441: ETRA4631CP
• 00810125990434: ETRAS4431CP
• 00810125990427: ETRA4431CP
• 00810125990410: ETRAS4721CP
• 00810125990403: ETRA4721CP
• 00810125990397: ETRAS4621CP
• 00810125990380: ETRA4621CP
• 00810125990373: ETRAS4421CP
• 00810125990366: ETRA4421CP
• 00810125990359: ETRAS4711CP
• 00810125990342: ETRA4711CP
• 00810125990328: ETRA4611CP
• 00810125990311: ETRAS4411CP
• 00810125990304: ETRA4411CP
• 00810125990298: ETRAS4750CP
• 00810125990281: ETRA4750CP
• 00810125990274: ETRAS4650CP
• 00810125990267: ETRA4650CP
• 00810125990250: ETRAS4450CP
• 00810125990243: ETRA4450CP
• 00810125990236: ETRAS4740CP
• 00810125990229: ETRA4740CP
• 00810125990212: ETRAS4640CP
• 00810125990205: ETRA4640CP
• 00810125990182: ETRA4440CP
• 00810125990175: ETRAS4730CP
• 00810125990168: ETRA4730CP
• 00810125990151: ETRAS4630CP
• 00810125990144: ETRA4630CP