Visionary by 3D Dental

Basic Information

• Brand Name: Visionary by 3D Dental
• Primary DI: 00810126506825
• Version / Model: XBAP1S
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
• Labeler DUNS: 080194935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-05
• Public Version: 1
• Public Version Date: 2026-03-13
• Public Version Status: New
• Public Device Record Key: 5e56fa5c-3ee3-4855-891c-022e59d32de7

Device Description

Visionary premium barrier opt style envelope #1 250/bx with extended tab pre-loaded with cardboard insert

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGZ	Holder, Film, X-Ray	Dental	872.1905	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66696	Dental digital imaging phosphor plate intraoral cover	An intraoral device in the form of an envelope or sleeve intended to cover a digital imaging phosphor plate prior to introduction into the oral cavity, to prevent cross-contamination between patients and/or shield the plate from ambient light. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810126506825	GS1