Dental LT Comfort Resin FLDLCO01

GUDID 00860002099354

FORMLABS OHIO INC.

Dental appliance fabrication material, resin

• Primary Device ID: 00860002099354
• NIH Device Record Key: b7753bea-63e9-4c05-9555-6aae11ad8a42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental LT Comfort Resin
• Version Model Number: FLDLCO01
• Catalog Number: FLDLCO01
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002099354 [Primary]

FDA Product Code

• KMY: Positioner, Tooth, Preformed
• 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: 2023-10-25
• Device Publish Date: 2023-10-17

On-Brand Devices [Dental LT Comfort Resin]

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