Identity
- Trade Name
- Visionary by 3D Dental FDA UDI
- Generic Name
- Digital imaging cassette/storage phosphor screen, dental FDA UDI
- Device Name
- VISIONARY BARRIER ENVELOPE #1 100/BX FDA UDI
- Model / Reference
- XBA1 FDA UDI
- Description
- VISIONARY BARRIER ENVELOPE #1 100/BX FDA UDI
Identifiers
- Catalog Number
- XBA1 FDA UDI
- Primary DI / UDI-DI
- 00817169025184 FDA UDI
- FDA Product Code
- EGZ FDA UDI
- GMDN Term
- Digital imaging cassette/storage phosphor screen, dental FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.1905 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Digital imaging cassette/storage phosphor screen, dental
Visionary by 3D Dental by 3d Dental Designs And Development, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Digital imaging cassette/storage phosphor screen, dental.
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- Unipack — Unipack Medical Corporation · Class I
- Stradis Medical, LLC. — STRADIS MEDICAL, LLC · Class II
- BENCO — BENCO DENTAL SUPPLY CO. · Class II
- ScanX Barrier Envelopes — Air Techniques, Inc. · Class II
- Defend — Young Innovations, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- 3d Dental Designs And Development, Llc
Sources (1)
- FDA UDI 7392eb95-cccf-42c7-9bc2-77e1676930bf 34 fields · synced May 30, 2026