HS II Fixture Mini RBM Pre-Mounted

GUDID 00814913022659

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913022659
• NIH Device Record Key: cfe6dd83-ec08-4700-a2a7-fdb4a43cefdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS II Fixture Mini RBM Pre-Mounted
• Version Model Number: AHS2M3508R18
• 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	00814913022659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080387

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 [HS II Fixture Mini RBM Pre-Mounted]

• 00814913022727: AHS2M3513R28
• 00814913022710: AHS2M3513R18
• 00814913022697: AHS2M3511R18
• 00814913022680: AHS2M3510R28
• 00814913022673: AHS2M3510R18
• 00814913022666: AHS2M3508R28
• 00814913022659: AHS2M3508R18