ET Angled Abutment_B With EG Screw

GUDID 00810019242151

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810019242151
• NIH Device Record Key: cde1206f-a35a-4efd-b18a-ffed3b868376
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET Angled Abutment_B With EG Screw
• Version Model Number: ETAGA452MBW
• 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	00810019242151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120847

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 Angled Abutment_B With EG Screw]

• 00810019242366: ETAGA604SBW
• 00810019242335: ETAGA602SBW
• 00810019242304: ETAGA554SBW
• 00810019242274: ETAGA552SBW
• 00810019242243: ETAGA454SBW
• 00810019242212: ETAGA452SBW
• 00810019242182: ETAGA454MBW
• 00810019242151: ETAGA452MBW
• 00810019242120: ETAGA434MBW
• 00810019242090: ETAGA432MBW