OrthoFX

GUDID 00860003321775

Boil and Bite Home Impression Kit.

ORTHOFX

Wax dental impression material

• Primary Device ID: 00860003321775
• NIH Device Record Key: 189308a7-8ca2-4a2f-bfd5-1eb0c00a0ebb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoFX
• Version Model Number: BB HIK
• Company DUNS: 033755180
• Company Name: ORTHOFX
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003321775 [Primary]

FDA Product Code

• EHY: Tray, Impression, 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: 2021-08-13
• Device Publish Date: 2021-08-05

On-Brand Devices [OrthoFX]

• 18600033217131: ZR1
• 18600033217377: TBR1
• 18600033217063: Z1
• 18600033217445: HIK1
• 00860003321706: Updated UDI submission for Zendura material aligners.
• 00860003321737: OrthoFX Retainer
• 00860003321713: OrthoFX Retainer
• 00086000332174: Tetra Bright Aligners Tetra Bright Aligners appears to whiten teeth while correcting dentition.
• 00860003321765: Tetra Bright Aligners Tetra Bright Aligners appears to whiten teeth while correcting dentition.
• 00860003321775: Boil and Bite Home Impression Kit.