Bar, Alignment, Universal
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Bar, Alignment, Universal EUDAMEDFDA UDIBar, Alignment, Universal, GENDEX EUDAMED
- Generic Name
- Dental x-ray film holder, reusable FDA UDI
- Device Name
- Intraoral Positioning System EUDAMED
- Model / Reference
- 1.008.1523 EUDAMEDFDA UDI0.860.0037 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- D090100815230 EUDAMEDFDA UDID090086000370 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D090ClassIJE EUDAMED
- Direct Marketing DI
- D090086000370 EUDAMEDD090100815230 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, Universal by Dental Imaging Technologies Corporation — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental x-ray film holder, reusable.
- RINN® — Dentsply International · Class I
- TrollByte — Directa AB · Class I
- XIOS XG — SIRONA DENTAL, INC. · Class II
- TrollByte — Directa AB · Class I
- AimRight Holder — SIRONA DENTAL, INC. · Class I
- CDR — SIRONA DENTAL, INC. · Class II
- TrollByte — Directa AB · Class I
- TrollByte — Directa AB · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dental Imaging Technologies Corporation
Sources (4)
- FDA UDI 363eb2e1-2c3f-4b9a-b18e-c54be6f14b03 32 fields · synced Jul 10, 2026
- FDA UDI 88bc52fe-c433-4db9-b296-3e3e20e4710e 32 fields · synced May 30, 2026
- EUDAMED b90d29d1-1c3d-49c3-bd55-6121fa435088 61 fields · synced Jul 9, 2026
- EUDAMED 198da4c5-e1a4-4081-9318-71b42680be05 61 fields · synced Jul 10, 2026