HM Implant Denture

GUDID 00814913022444

HIOSSEN, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913022444
• NIH Device Record Key: 58156e54-ef0d-4d19-ae03-ddb4a3659f81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HM Implant Denture
• Version Model Number: HMD2513R04
• 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	00814913022444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083067

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 [HM Implant Denture]

• 00814913022529: HMD3015R04
• 00814913022512: HMD3015R02
• 00814913022505: HMD3013R04
• 00814913022499: HMD3013R02
• 00814913022482: HMD3010R04
• 00814913022475: HMD3010R02
• 00814913022468: HMD2515R04
• 00814913022451: HMD2515R02
• 00814913022444: HMD2513R04
• 00814913022437: HMD2513R02
• 00814913022420: HMD2510R04
• 00814913022413: HMD2510R02