HG III Fixture RBM Regular Pre-Mounted

GUDID 00814913021911

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913021911
• NIH Device Record Key: 1ada6ada-5097-4785-97ce-abf901f8613a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HG III Fixture RBM Regular Pre-Mounted
• Version Model Number: AHG3S4008R
• 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	00814913021911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082213

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 III Fixture RBM Regular Pre-Mounted]

• 00814913022079: AHG3S5015R
• 00814913022062: AHG3S5013R
• 00814913022055: AHG3S5011R
• 00814913022048: AHG3S5010R
• 00814913022031: AHG3S5008R
• 00814913022024: AHG3S5007R
• 00814913022017: AHG3S4515R
• 00814913022000: AHG3S4513R
• 00814913021997: AHG3S4511R
• 00814913021980: AHG3S4510R
• 00814913021973: AHG3S4508R
• 00814913021966: AHG3S4507R
• 00814913021959: AHG3S4015R
• 00814913021942: AHG3S4013R
• 00814913021935: AHG3S4011R
• 00814913021928: AHG3S4010R
• 00814913021911: AHG3S4008R
• 00814913021904: AHG3S4007R