HG II Fixture RBM Regular No Mount

GUDID 00814913021584

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913021584
• NIH Device Record Key: 931a70eb-aba3-4980-95d0-f324b6126364
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HG II Fixture RBM Regular No Mount
• Version Model Number: CHG2S4008R
• 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	00814913021584 [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 Fixture RBM Regular No Mount]

• 00814913021744: CHG2S5015R
• 00814913021737: CHG2S5013R
• 00814913021720: CHG2S5011R
• 00814913021713: CHG2S5010R
• 00814913021706: CHG2S5008R
• 00814913021690: CHG2S5007R
• 00814913021683: CHG2S4515R
• 00814913021676: CHG2S4513R
• 00814913021669: CHG2S4511R
• 00814913021652: CHG2S4510R
• 00814913021645: CHG2S4508R
• 00814913021638: CHG2S4507R
• 00814913021621: CHG2S4015R
• 00814913021614: CHG2S4013R
• 00814913021607: CHG2S4011R
• 00814913021591: CHG2S4010R
• 00814913021584: CHG2S4008R
• 00814913021577: CHG2S4007R