Premium Teeth Resin - HT Bleach

GUDID 00850061175007

Premium Teeth Resin (HT Bleach) for cartridge v2

FORMLABS OHIO INC.

Resin artificial teeth

• Primary Device ID: 00850061175007
• NIH Device Record Key: 34aec7f4-7c6a-4660-969d-91894173c319
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium Teeth Resin - HT Bleach
• Version Model Number: FLPTBL01
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850061175007 [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: 2024-05-02
• Device Publish Date: 2024-04-24

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

• 00860002099392: Premium Teeth Resin is a light-curable nano-ceramic composite resin designed for the fabrication
• 00850061175007: Premium Teeth Resin (HT Bleach) for cartridge v2