ET STUD ABUTMENT SET

GUDID 00810019241437

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810019241437
• NIH Device Record Key: 95767161-cc42-4791-81e2-18a95046ac11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET STUD ABUTMENT SET
• Version Model Number: ETSAO355S
• 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	00810019241437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161689

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

On-Brand Devices [ET STUD ABUTMENT SET]

• 00810019241444: ETSAO356S
• 00810019241437: ETSAO355S
• 00810019241420: ETSAO354S
• 00810019241413: ETSAO353S
• 00810019241406: ETSAO352S
• 00810019241390: ETSAO351S
• 00810019241383: ETSAO356M
• 00810019241376: ETSAO355M
• 00810019241369: ETSAO354M
• 00810019241352: ETSAO353M
• 00810019241345: ETSAO352M
• 00810019241338: ETSAO351M