Dental LT Comfort Resin

GUDID 00850061175106

Dental LT Comfort (V1.1) used with Cartridge V2

FORMLABS OHIO INC.

Dental appliance fabrication material, resin

• Primary Device ID: 00850061175106
• NIH Device Record Key: 6aa0b084-855e-4d1f-9b1e-5235ead86117
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental LT Comfort Resin
• Version Model Number: FLDLCO11
• Company DUNS: 106744280
• Company Name: FORMLABS OHIO 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850061175106 [Primary]

FDA Product Code

• MQC: Mouthguard, Prescription

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 [Dental LT Comfort Resin]

• 00860002099354: FLDLCO01
• 00850061175106: Dental LT Comfort (V1.1) used with Cartridge V2