ET EsthTSic-low Ti Cylinder Screw

GUDID 00810125995873

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810125995873
• NIH Device Record Key: 8b76f1fa-0075-4b6f-b2f2-ab94e64a35ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET EsthTSic-low Ti Cylinder Screw
• Version Model Number: ETMTS200C
• 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	00810125995873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222636

FDA Product Code

• NDP: Accessories, 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

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• 00810126040039 - EK III NH Fixture Pre-Mounted: 2024-09-26
• 00810126040046 - EK III NH Fixture Pre-Mounted: 2024-09-26
• 00810126040053 - EK III NH Fixture Pre-Mounted: 2024-09-26
• 00810126040060 - EK III NH Fixture Pre-Mounted: 2024-09-26
• 00810126040077 - EK III NH Fixture Pre-Mounted: 2024-09-26