ET RIGID LAB ANALOG

GUDID 00810125991523

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810125991523
• NIH Device Record Key: 82a877f4-8c75-4768-9772-288fdd6b9149
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET RIGID LAB ANALOG
• Version Model Number: ETRLA570C
• 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: false
• 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	00810125991523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222636

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-15
• Device Publish Date: 2024-07-05

On-Brand Devices [ET RIGID LAB ANALOG]

• 00810019240706: ETRLA7005S
• 00810019240690: ETRLA6007S
• 00810019240683: ETRLA6005S
• 00810019240676: ETRLA6004S
• 00810019240669: ETRLA5007S
• 00810019240652: ETRLA5005S
• 00810019240645: ETRLA5004S
• 00810019240638: ETRLA4507
• 00810019240621: ETRLA4505
• 00810019240614: ETRLA4504
• 00810019240607: ETRLA4007
• 00810019240591: ETRLA4005
• 00810019240584: ETRLA4004
• 00810125991561: ETRLA760C
• 00810125991554: ETRLA670C
• 00810125991547: ETRLA660C
• 00810125991530: ETRLA640C
• 00810125991516: ETRLA560C
• 00810125991509: ETRLA540C
• 00810125991493: ETRLA471C
• 00810125991486: ETRLA461C
• 00810125991479: ETRLA441C
• 00810125991462: ETRLA470C
• 00810125991455: ETRLA460C
• 00810125991448: ETRLA440C
• 00810125991523: ETRLA570C