ET Rigid Burn-out Cylinder

GUDID 00810125991363

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810125991363
• NIH Device Record Key: 5b477152-89e4-4fd2-aec0-bbef3cf79444
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET Rigid Burn-out Cylinder
• Version Model Number: ETRP450SC
• 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	00810125991363 [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: 2024-07-11
• Device Publish Date: 2024-07-03

On-Brand Devices [ET Rigid Burn-out Cylinder]

• 00810019240577: ETRBC70SB
• 00810019240560: ETRBC70SS
• 00810019240553: ETRBC60SB
• 00810019240546: ET Rigid Burn-out Cylinder
• 00810019240539: ETRBC50SB
• 00810019240522: ETRBC50SS
• 00810019240515: ETRBC45B
• 00810019240508: ETRBC45S
• 00810019240492: ETRBC40B
• 00810019240485: ETRBC40S
• 00810125991431: ETRP700BC
• 00810125991424: ETRP700SC
• 00810125991417: ETRP600BC
• 00810125991400: ETRP600SC
• 00810125991394: ETRP500BC
• 00810125991387: ETRP500SC
• 00810125991370: ETRP450BC
• 00810125991363: ETRP450SC
• 00810125991356: ETRP400BC
• 00810125991349: ETRP400SC