ET BITE INDEX

GUDID 00810125994609

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810125994609
• NIH Device Record Key: 65d98194-d39c-4a7b-9524-44b7928d20de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET BITE INDEX
• Version Model Number: ETBIS5506SC
• 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	00810125994609 [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: 2024-07-15
• Device Publish Date: 2024-07-06

On-Brand Devices [ET BITE INDEX]

• 00810019241666: ETBIS5512S
• 00810019241659: ETBIS5510S
• 00810019241642: ETBIS5508S
• 00810019241635: ETBIS5506S
• 00810019241628: ETBIS5504S
• 00810019241611: ETBIM4512S
• 00810019241604: ETBIM4510S
• 00810019241598: ETBIM4508S
• 00810019241581: ETBIM4506S
• 00810019241574: ETBIM4504S
• 00810125994630: ETBIS5512SC
• 00810125994623: ETBIS5510SC
• 00810125994616: ETBIS5508SC
• 00810125994609: ETBIS5506SC
• 00810125994593: ETBIS5504SC
• 00810125994586: ETBIM4512SC
• 00810125994579: ETBIM4510SC
• 00810125994562: ETBIM4508SC
• 00810125994555: ETBIM4506SC
• 00810125994548: ETBIM4504SC