Premium Teeth Resin - HT B1

GUDID 00860002099385

Premium Teeth Resin is a light-curable nano-ceramic composite resin designed for the fabrication of 3D printed dental appliances, such as denture teeth for complete and partial removable dentures, try-in dentures, and provisional full-arch implant-supported restorations.

FORMLABS OHIO INC.

Resin artificial teeth

• Primary Device ID: 00860002099385
• NIH Device Record Key: c02bc04c-1841-47d5-a47e-f810bd4282c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium Teeth Resin - HT B1
• Version Model Number: FLPTB101
• 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: false
• 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	00860002099385 [Primary]

FDA Product Code

• PZY: Additively Manufactured, Preformed, Resin Denture Tooth

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: 2024-02-09
• Device Publish Date: 2024-02-01

On-Brand Devices [Premium Teeth Resin - HT B1]

• 00860002099385: Premium Teeth Resin is a light-curable nano-ceramic composite resin designed for the fabrication
• 00850061175021: Premium Teeth Resin (HT B1) for cartridge v2