Dental LT Clear Resin V2 FLDLCL02

GUDID 10860002099337

FORMLABS OHIO INC.

Dental appliance fabrication material, cured

• Primary Device ID: 10860002099337
• NIH Device Record Key: e04f12a0-ccb7-4473-9281-dd5a472ecebe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental LT Clear Resin V2
• Version Model Number: FLDLCL02
• Catalog Number: FLDLCL02
• 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: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002099330 [Primary]
GS1	10860002099337 [Package]; Contains: 00860002099330; Package: Case [8 Units]; In Commercial Distribution

FDA Product Code

• KMY: Positioner, Tooth, Preformed

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: 2020-07-15
• Device Publish Date: 2020-07-07

Devices Manufactured by FORMLABS OHIO INC.

• 00850061175007 - Premium Teeth Resin - HT Bleach: 2024-05-02 Premium Teeth Resin (HT Bleach) for cartridge v2
• 00850061175014 - Premium Teeth Resin - HT A2: 2024-05-02 Premium Teeth Resin (HT A2) for cartridge v2
• 00850061175021 - Premium Teeth Resin - HT B1: 2024-05-02 Premium Teeth Resin (HT B1) for cartridge v2
• 00850061175038 - Premium Teeth Resin - HT A3: 2024-05-02 Premium Teeth Resin (HT A3) for cartridge v2
• 00850061175069 - Custom Tray Resin: 2024-05-02 Custom Tray Resin for cartridge v2
• 00850061175076 - Dental LT Clear V2: 2024-05-02 Dental LT Clear V2 for cartridge V2
• 00850061175083 - IBT Flex Resin: 2024-05-02 IBT Flex Resin for cartridge V2
• 00850061175090 - Surgical Guide Resin: 2024-05-02 Surgical Guide Resin for cartridge V2