HS II Fixture Wide RBM Pre-Mounted

GUDID 00814913023168

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913023168
• NIH Device Record Key: baa6e667-11d8-414e-b204-4eea96fcb439
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS II Fixture Wide RBM Pre-Mounted
• Version Model Number: AHS2W5010R20
• 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	00814913023168 [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 Wide RBM Pre-Mounted]

• 00814913023199: AHS2W5015R20
• 00814913023182: AHS2W5013R20
• 00814913023175: AHS2W5011R20
• 00814913023168: AHS2W5010R20
• 00814913023151: AHS2W5008R20
• 00814913023144: AHS2W5007R20
• 00814913023137: AHS2W4515R20
• 00814913023120: AHS2W4513R20
• 00814913023113: AHS2W4511R20
• 00814913023106: AHS2W4510R20
• 00814913023090: AHS2W4508R20
• 00814913023083: AHS2W4507R20