ET III Fixture SA Regular No Mount

GUDID 00814913021119

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913021119
• NIH Device Record Key: 787c4d09-189f-4e6e-913d-cb58624b98ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III Fixture SA Regular No Mount
• Version Model Number: CET3R4513S
• 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	00814913021119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140934

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: 2015-09-01

On-Brand Devices [ET III Fixture SA Regular No Mount]

• 00814913021188: CET3R5015S
• 00814913021171: CET3R5013S
• 00814913021164: CET3R5011S
• 00814913021157: CET3R5010S
• 00814913021140: CET3R5008S
• 00814913021133: CET3R5007S
• 00814913021126: CET3R4515S
• 00814913021119: CET3R4513S
• 00814913021102: CET3R4511S
• 00814913021096: CET3R4510S
• 00814913021089: CET3R4508S
• 00814913021072: CET3R4507S
• 00814913021065: CET3R4015S
• 00814913021058: CET3R4013S
• 00814913021041: CET3R4011S
• 00814913021034: CET3R4010S
• 00814913021027: CET3R4008S
• 00814913021010: CET3R4007S
• 00814913029733: CET3R5006S
• 00810126044785: CET3R5015S
• 00810126044761: CET3R5013S
• 00810126044747: CET3R5011S
• 00810126044723: CET3R5010S
• 00810126044709: CET3R5008S
• 00810126044686: CET3R5007S
• 00810126044662: CET3R5006S
• 00810126044648: CET3R4515S
• 00810126044624: CET3R4513S
• 00810126044600: CET3R4511S
• 00810126044587: CET3R4510S
• 00810126044563: CET3R4508S
• 00810126044549: CET3R4507S
• 00810126044525: CET3R4015S
• 00810126044501: CET3R4013S
• 00810126044488: CET3R4011S
• 00810126044464: CET3R4010S
• 00810126044440: CET3R4008S
• 00810126044426: CET3R4007S