EK New scan body

GUDID 00810125999215

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810125999215
• NIH Device Record Key: 7e978849-cd0a-4354-aa49-13fb64479f5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EK New scan body
• Version Model Number: EKNSBETH
• Company DUNS: 796083090
• Company Name: HIOSSEN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00810125999215 [Primary]

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: 2024-06-25
• Device Publish Date: 2024-06-17

Devices Manufactured by HIOSSEN, INC.

• 00810125999154 - EK Onefit Abutment: 2024-06-25
• 00810125999161 - EK Onefit Abutment: 2024-06-25
• 00810125999178 - EK Onefit Abutment(Gold): 2024-06-25
• 00810125999185 - EK Onefit Abutment(Gold): 2024-06-25
• 00810125999192 - EK New scan body: 2024-06-25
• 00810125999208 - EK New scan body: 2024-06-25
• 00810125999215 - EK New scan body: 2024-06-25
• 00810125999215 - EK New scan body: 2024-06-25
• 00810125999116 - ET Multi Angled Abutment: 2024-05-15