Identity
- Trade Name
- Darby Dental Supply, LLC FDA UDI
- Generic Name
- Digital imaging phosphor plate, dental, intraoral FDA UDI
- Device Name
- PHOSPHR IMGE PLATE GENDEX SZ0 FDA UDI
- Model / Reference
- 5252544 FDA UDI
- Description
- PHOSPHR IMGE PLATE GENDEX SZ0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889813062005 FDA UDI
- FDA Product Code
- EAM FDA UDI
- GMDN Term
- Digital imaging phosphor plate, dental, intraoral FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1960 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Category: Digital imaging phosphor plate, dental, intraoral
Darby Dental Supply, LLC by Darby Dental Supply, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Digital imaging phosphor plate, dental, intraoral.
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- Phosphor Storage Plate IDX S4 — DÜRR DENTAL SE · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · 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
- Darby Dental Supply, Llc
Sources (1)
- FDA UDI 6d41f365-bf50-4eaa-917c-96ed2fec1d78 33 fields · synced Jun 6, 2026