TrueDent OBJ-09164

GUDID 07290018915004

Stratasys TrueDent™ is Stratasys TrueDent™ is a light-curable resin indicated for the fabrication of dental appliances including removable full and partial dentures, denture bases, denture teeth, bridges, crowns, inlays, onlays, and veneers in dental laboratories. The material is an alternative to traditional heat-curable and auto polymerizing resins. Stratasys TrueDent™ is intended exclusively for professional dental work. Fabrication of dental appliances with Stratasys TrueDent™ requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression, a Stratasys PolyJet 3D printer, and curing light equipment.

STRATASYS LTD

Dental appliance fabrication material, resin

• Primary Device ID: 07290018915004
• NIH Device Record Key: 97296b7b-29e5-47f6-bdc6-162a1101863c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrueDent
• Version Model Number: TrueDent Clear
• Catalog Number: OBJ-09164
• Company DUNS: 532091048
• Company Name: STRATASYS LTD
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.
• Special Storage Condition, Specify: Between 0 and 0 *Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290018915004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220771

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2023-03-14
• Device Publish Date: 2023-03-06

On-Brand Devices [TrueDent ]

• 07290018915806: Stratasys TrueDent™ is Stratasys TrueDent™ is a light-curable resin indicated for the fabric
• 07290018915608: Stratasys TrueDent™ is Stratasys TrueDent™ is a light-curable resin indicated for the fabric
• 07290018915400: Stratasys TrueDent™ is Stratasys TrueDent™ is a light-curable resin indicated for the fabric
• 07290018915202: Stratasys TrueDent™ is Stratasys TrueDent™ is a light-curable resin indicated for the fabric
• 07290018915004: Stratasys TrueDent™ is Stratasys TrueDent™ is a light-curable resin indicated for the fabric