ET III Fixture NH Regular No-Mounted

GUDID 00814913023939

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913023939
• NIH Device Record Key: 898c031f-5b74-4c56-8590-7a0972e1135b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III Fixture NH Regular No-Mounted
• Version Model Number: CET3R5008B
• 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	00814913023939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151626

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: 2016-08-04

On-Brand Devices [ET III Fixture NH Regular No-Mounted]

• 00814913023977: CET3R5015B
• 00814913023960: CET3R5013B
• 00814913023953: CET3R5011B
• 00814913023946: CET3R5010B
• 00814913023939: CET3R5008B
• 00814913023922: CET3R5007B
• 00814913023915: CET3R4515B
• 00814913023908: CET3R4513B
• 00814913023892: CET3R4511B
• 00814913023885: CET3R4510B
• 00814913023878: CET3R4508B
• 00814913023861: CET3R4507B
• 00814913023854: CET3R4015B
• 00814913023847: CET3R4013B
• 00814913023830: CET3R4011B
• 00814913023823: CET3R4010B
• 00814913023816: CET3R4008B
• 00814913023809: CET3R4007B
• 00814913029627: CET3R5006B