IBT Flex Resin

GUDID 00850061175083

IBT Flex Resin for cartridge V2

FORMLABS OHIO INC.

Dental appliance fabrication material, resin

• Primary Device ID: 00850061175083
• NIH Device Record Key: 8f68d75b-bf39-4ae4-b7ba-a06fe26f8c08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IBT Flex Resin
• Version Model Number: FLIBFL01
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850061175083 [Primary]

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: 2024-05-02
• Device Publish Date: 2024-04-24

On-Brand Devices [IBT Flex Resin ]

• 10886000209936: IBT Flex Resin is a light-curable polymer based material designed for 3D printing biocompatible,
• 00850061175083: IBT Flex Resin for cartridge V2