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Holder, Horiz BW, Snap-In, IXS Size 2
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 1.013.2911
Identity
- Trade Name
- Holder, Horiz BW, DEXIS IXS, Size 2 EUDAMEDHolder, Horiz BW, Snap-In, IXS Size 2 FDA UDI
- Generic Name
- Dental x-ray film holder, reusable FDA UDI
- Device Name
- Intraoral Positioning System EUDAMED
- Model / Reference
- 1.013.2911 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- D090101329110 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D090ClassIJE EUDAMED
- FDA Product Code
- EGZ 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
- 872.1905 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
Holder, Horiz BW, Snap-In, IXS Size 2 by Dental Imaging Technologies Corporation — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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
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 ea9e810f-29e1-428d-9d9e-cd099a88c1e9 32 fields · synced Jun 19, 2026
- EUDAMED 51fe2e28-3139-4b1b-96b1-415532ccec68 61 fields · synced Jun 19, 2026