ET III Fixture SA Regular Pre-Mounted

GUDID 00814913020747

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913020747
• NIH Device Record Key: 95476464-bec4-4000-a6ab-1d3d7c2624e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III Fixture SA Regular Pre-Mounted
• Version Model Number: AET3R4515S
• 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	00814913020747 [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 Pre-Mounted]

• 00814913020839: AET3R5018S
• 00814913020822: AET3R5015S
• 00814913020815: AET3R5013S
• 00814913020808: AET3R5011S
• 00814913020792: AET3R5010S
• 00814913020785: AET3R5008S
• 00814913020778: AET3R5007S
• 00814913020754: AET3R4518S
• 00814913020747: AET3R4515S
• 00814913020730: AET3R4513S
• 00814913020723: AET3R4511S
• 00814913020716: AET3R4510S
• 00814913020709: AET3R4508S
• 00814913020693: AET3R4507S
• 00814913020686: AET3R4018S
• 00814913020679: AET3R4015S
• 00814913020662: AET3R4013S
• 00814913020655: AET3R4011S
• 00814913020648: AET3R4010S
• 00814913020631: AET3R4008S
• 00814913020624: AET3R4007S
• 00810126043566: AET3R4018S
• 00810126043559: AET3R4015S
• 00810126043535: AET3R4013S
• 00810126043849: AET3R5018S
• 00810126043832: AET3R5015S
• 00810126043818: AET3R5013S
• 00810126043795: AET3R5011S
• 00810126043771: AET3R5010S
• 00810126043757: AET3R5008S
• 00810126043733: AET3R5007S
• 00810126043719: AET3R5006S
• 00810126043696: AET3R4518S
• 00810126043689: AET3R4515S
• 00810126043665: AET3R4513S
• 00810126043641: AET3R4511S
• 00810126043627: AET3R4510S
• 00810126043603: AET3R4508S
• 00810126043580: AET3R4507S
• 00810126043511: AET3R4011S