HG III Fixture RBM Regular No Mount

GUDID 00814913022376

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913022376
• NIH Device Record Key: 6e1ccfcd-f012-43e6-bc69-1cf714271452
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HG III Fixture RBM Regular No Mount
• Version Model Number: CHG3S5010R
• 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	00814913022376 [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: 2015-09-08

On-Brand Devices [HG III Fixture RBM Regular No Mount]

• 00814913022406: CHG3S5015R
• 00814913022390: CHG3S5013R
• 00814913022383: CHG3S5011R
• 00814913022376: CHG3S5010R
• 00814913022369: CHG3S5008R
• 00814913022352: CHG3S5007R
• 00814913022345: CHG3S4515R
• 00814913022338: CHG3S4513R
• 00814913022321: CHG3S4511R
• 00814913022314: CHG3S4510R
• 00814913022307: CHG3S4508R
• 00814913022291: CHG3S4507R
• 00814913022284: CHG3S4015R
• 00814913022277: CHG3S4013R
• 00814913022260: CHG3S4011R
• 00814913022253: CHG3S4010R
• 00814913022246: CHG3S4008R
• 00814913022239: CHG3S4007R