OrthoFX Aligner

GUDID 00860003321799

FXTetra Clear Aligner 2.0

ORTHOFX

Orthodontic progressive aligner

• Primary Device ID: 00860003321799
• NIH Device Record Key: a0c483d3-d850-44bc-9bfb-f19bb0153d2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoFX Aligner
• Version Model Number: 019
• Company DUNS: 033755180
• Company Name: ORTHOFX
• 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: true
• Manufacturing Date: true
• 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	00860003321799 [Primary]

FDA Product Code

• NXC: Aligner, Sequential

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: 2023-10-09
• Device Publish Date: 2023-09-29

Devices Manufactured by ORTHOFX

• 00860003321799 - OrthoFX Aligner: 2023-10-09FXTetra Clear Aligner 2.0
• 00860003321799 - OrthoFX Aligner: 2023-10-09 FXTetra Clear Aligner 2.0
• 00860003321782 - OrthoFX NiTime Aligner: 2023-09-29
• 00860003321775 - OrthoFX: 2021-08-13 Boil and Bite Home Impression Kit.
• 00860003321765 - OrthoFX: 2021-05-07 Tetra Bright Aligners Tetra Bright Aligners appears to whiten teeth while correcting dentition.
• 00086000332174 - OrthoFX: 2021-05-06 Tetra Bright Aligners Tetra Bright Aligners appears to whiten teeth while correcting dentition.
• 00860003321713 - OrthoFX: 2020-12-02 OrthoFX Retainer
• 00860003321720 - Glo Science: 2020-12-02 Over the counter teeth whitening gel
• 00860003321737 - OrthoFX: 2020-12-02 OrthoFX Retainer