ET III Fixture BA Regular Pre-Mounted

GUDID 00814913020150

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913020150
• NIH Device Record Key: 92f7e2ad-18f2-4a0c-8199-7d3d73b8953e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III Fixture BA Regular Pre-Mounted
• Version Model Number: AET3R4513B
• 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	00814913020150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112532

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 BA Regular Pre-Mounted]

• 00814913020228: AET3R5015B
• 00814913020211: AET3R5013B
• 00814913020204: AET3R5011B
• 00814913020198: AET3R5010B
• 00814913020181: AET3R5008B
• 00814913020174: AET3R5007B
• 00814913020167: AET3R4515B
• 00814913020150: AET3R4513B
• 00814913020143: AET3R4511B
• 00814913020136: AET3R4510B
• 00814913020129: AET3R4508B
• 00814913020112: AET3R4507B
• 00814913020105: AET3R4015B
• 00814913020099: AET3R4013B
• 00814913020082: AET3R4011B
• 00814913020075: AET3R4010B
• 00814913020068: AET3R4008B
• 00814913020051: AET3R4007B