Bar, Alignment, Endodontic
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Endodontic Bar - Alignment Bar EUDAMEDFDA UDIBar, Alignment, Endodontic, GENDEX EUDAMEDBar, Alignment, Endodontic FDA UDI
- Generic Name
- Dental x-ray film holder, reusable FDA UDI
- Device Name
- Intraoral Positioning System EUDAMED
- Model / Reference
- 1.008.1524 EUDAMEDFDA UDI0.822.5129 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- D090100815240 EUDAMEDFDA UDID090082251290 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D090ClassIJE EUDAMED
- Direct Marketing DI
- D090100815240 EUDAMEDD090082251290 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental x-ray film holder, reusable
Bar, Alignment, Endodontic 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
MDR
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 (4)
- FDA UDI 73f72c60-ee8a-418a-8923-c26719416c00 32 fields · synced Aug 1, 2026
- FDA UDI 973a3a96-1d5f-4f88-9838-b0f6626b0ca5 32 fields · synced May 30, 2026
- EUDAMED e9438d30-c9ca-47f5-9071-6531a90447b6 61 fields · synced Jul 11, 2026
- EUDAMED 96ca5910-34a2-4cb0-9927-e5a469687007 61 fields · synced Jul 28, 2026