HM Implant Narrow Ridge

GUDID 00814913022611

HIOSSEN, INC.

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

• Primary Device ID: 00814913022611
• NIH Device Record Key: 790be9ad-34db-46ee-95c2-264d6e0ea63b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HM Implant Narrow Ridge
• Version Model Number: HMN3013R03
• 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	00814913022611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080594

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 Narrow Ridge]

• 00814913022642: HMN3015R04
• 00814913022635: HMN3015R03
• 00814913022628: HMN3013R04
• 00814913022611: HMN3013R03
• 00814913022604: HMN3010R04
• 00814913022598: HMN3010R03
• 00814913022581: HMN2515R04
• 00814913022574: HMN2515R03
• 00814913022567: HMN2513R04
• 00814913022550: HMN2513R03
• 00814913022543: HMN2510R04
• 00814913022536: HMN2510R03