← Back to catalogue
Holder, Anterior, Snap-In, DEXIS
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 1.013.1098Ref 1.010.4305
Identity
- Trade Name
- Holder, Anterior, DEXIS Ti2/Titanium EUDAMEDHolder, Anterior, DEXIS EUDAMEDHolder, Anterior, Snap-In, DEXIS FDA UDI
- Generic Name
- Dental x-ray film holder, reusable FDA UDI
- Device Name
- Intraoral Positioning System EUDAMED
- Model / Reference
- 1.013.1098 EUDAMEDFDA UDI1.010.4305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D090101310980 EUDAMEDFDA UDID090101043050 EUDAMED
- 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, Anterior, Snap-In, DEXIS 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dental Imaging Technologies Corporation
Sources (3)
- FDA UDI 5d2249fc-b1e7-421c-a284-d75242a877bb 32 fields · synced Sep 17, 2026
- EUDAMED 2e12f6f0-c6c0-427b-81ab-77a171576969 61 fields · synced Jun 19, 2026
- EUDAMED 4bb12ad9-15e6-45bf-ade6-ec61717df329 61 fields · synced Sep 17, 2026