HG II Fixture Regular RBM Pre-Mounted

GUDID 00814913021294

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913021294
• NIH Device Record Key: 9afbaaac-4aca-44a3-9cb1-480ae5ed85d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HG II Fixture Regular RBM Pre-Mounted
• Version Model Number: AHG2S4015R
• 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	00814913021294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090237

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: 2015-09-01

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

• 00814913021416: AHG2S5015R
• 00814913021409: AHG2S5013R
• 00814913021393: AHG2S5011R
• 00814913021386: AHG2S5010R
• 00814913021379: AHG2S5008R
• 00814913021362: AHG2S5007R
• 00814913021355: AHG2S4515R
• 00814913021348: AHG2S4513R
• 00814913021331: AHG2S4511R
• 00814913021324: AHG2S4510R
• 00814913021317: AHG2S4508R
• 00814913021300: AHG2S4507R
• 00814913021294: AHG2S4015R
• 00814913021287: AHG2S4013R
• 00814913021270: AHG2S4011R
• 00814913021263: AHG2S4010R
• 00814913021256: AHG2S4008R
• 00814913021249: AHG2S4007R