Esthetic-low Gold Cylinder

GUDID 00810019241772

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810019241772
• NIH Device Record Key: 0441d813-3e49-4c4e-b214-50f971b1daf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esthetic-low Gold Cylinder
• Version Model Number: ETMGR200TH
• 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	00810019241772 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140507

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: 2019-05-23
• Device Publish Date: 2019-05-15

On-Brand Devices [Esthetic-low Gold Cylinder]

• 00810019241796: ETMGW200TH
• 00810019241789: ETMGW100TH
• 00810019241772: ETMGR200TH
• 00810019241765: ETMGR100TH