Identity
- Trade Name
- Bar, Alignment, Bitewing, GENDEX EUDAMEDBar, Alignment, Bitewing FDA UDI
- Generic Name
- Dental x-ray film holder, reusable FDA UDI
- Device Name
- Intraoral Positioning System EUDAMED
- Model / Reference
- 1.008.1522 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- D090100815220 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D090ClassIJE EUDAMED
- Direct Marketing DI
- D090100815220 EUDAMED
- FDA Product Code
- EHA FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Dental x-ray film holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.1820 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Dental x-ray film holder, reusable
Bar, Alignment, Bitewing by Dental Imaging Technologies Corporation — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dental Imaging Technologies Corporation
Sources (2)
- FDA UDI 1d4ad791-6f30-4a32-b791-6c719d22df23 32 fields · synced Jul 17, 2026
- EUDAMED 469373aa-d802-41a3-8095-3175d1cb3ec6 61 fields · synced Jul 17, 2026