HS II Fixture Regular RBM Pre-Mounted

GUDID 00814913023038

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913023038
• NIH Device Record Key: fe458283-7277-44be-93eb-094a6f818849
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS II Fixture Regular RBM Pre-Mounted
• Version Model Number: AHS2R5011R28
• 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	00814913023038 [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 Regular RBM Pre-Mounted]

• 00814913023076: AHS2R5015R28
• 00814913023069: AHS2R5015R18
• 00814913023052: AHS2R5013R28
• 00814913023045: AHS2R5013R18
• 00814913023038: AHS2R5011R28
• 00814913023021: AHS2R5011R18
• 00814913023014: AHS2R5010R28
• 00814913023007: AHS2R5010R18
• 00814913022994: AHS2R5008R28
• 00814913022987: AHS2R5008R18
• 00814913022970: AHS2R5007R18
• 00814913022963: AHS2R4515R28
• 00814913022956: AHS2R4515R18
• 00814913022949: AHS2R4513R28
• 00814913022932: AHS2R4513R18
• 00814913022925: AHS2R4511R28
• 00814913022918: AHS2R4511R18
• 00814913022901: AHS2R4510R28
• 00814913022895: AHS2R4510R18
• 00814913022888: AHS2R4508R28
• 00814913022871: AHS2R4508R18
• 00814913022864: AHS2R4507R18
• 00814913022857: AHS2R4015R28
• 00814913022840: AHS2R4015R18
• 00814913022833: AHS2R4013R28
• 00814913022826: AHS2R4013R18
• 00814913022819: AHS2R4011R28
• 00814913022802: AHS2R4011R18
• 00814913022796: AHS2R4010R28
• 00814913022789: AHS2R4010R18
• 00814913022772: AHS2R4008R28
• 00814913022765: AHS2R4008R18
• 00814913022758: AHS2R4007R18