IBT Resin

GUDID 10860002099344

IBT Resin is a light-curable polymer based material designed for 3D printing biocompatible, indirect bonding trays for dental bracket placement. Users should independently verify the suitability of the printed materials for their particular application and intended purpose. IBT Resin is a photopolymer resin made of a mixture of methacrylic esters and photoinitiators.

FORMLABS OHIO INC.

Dental appliance fabrication material, cured

• Primary Device ID: 10860002099344
• NIH Device Record Key: 23e076d0-5b99-4013-bf4a-45bab07bd6cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IBT Resin
• Version Model Number: FLIBCL01
• Company DUNS: 106744280
• Company Name: FORMLABS OHIO INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: true

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002099347 [Primary]
GS1	10860002099344 [Package]; Contains: 00860002099347; Package: Case [8 Units]; In Commercial Distribution

FDA Product Code

• EBH: Material, Impression Tray, Resin

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: 2021-02-24
• Device Publish Date: 2021-02-16

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