HG II Ultra-Wide Fixture RBM Pre-Mounted

GUDID 00814913021492

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913021492
• NIH Device Record Key: c0bb1ff1-5b18-4a81-8262-215e2b782ef6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HG II Ultra-Wide Fixture RBM Pre-Mounted
• Version Model Number: AHG2S7010R
• 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: true
• 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	00814913021492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073465

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-02

On-Brand Devices [HG II Ultra-Wide Fixture RBM Pre-Mounted]

• 00814913021515: AHG2S7013R
• 00814913021508: AHG2S7011R
• 00814913021492: AHG2S7010R
• 00814913021485: AHG2S7008R
• 00814913021478: AHG2S7007R
• 00814913021461: AHG2S6013R
• 00814913021454: AHG2S6011R
• 00814913021447: AHG2S6010R
• 00814913021430: AHG2S6008R
• 00814913021423: AHG2S6007R