Identity
- Trade Name
- DiaPrep Pro EUDAMEDFDA UDI
- Generic Name
- Root canal cleaning solution FDA UDI
- Device Name
- DiaPrep Pro EUDAMEDDiaPrep Pro is an EDTA cream with Urea Hydrogen Peroxide, used as an irrigation agent for chemomechanical preparation of the root canal FDA UDI
- Model / Reference
- DiaPrep Pro 6g EUDAMED2002-4100 EUDAMED6g FDA UDI
- Description
- DiaPrep Pro is an EDTA cream with Urea Hydrogen Peroxide, used as an irrigation agent for chemomechanical preparation of the root canal FDA UDI
Identifiers
- Catalog Number
- 2002-4100 FDA UDI
- Primary DI / UDI-DI
- 08806383560412 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08806383560412 EUDAMED
- FDA Product Code
- EKQ FDA UDI
- EMDN Code
- Q01010302 SOLUTIONS FOR CANAL IRRIGATION EUDAMED
- GMDN Term
- Root canal cleaning solution FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DiaPrep Pro by Diadent Group International — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08806383560412 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Diadent Group International
- EUDAMED SRN
- KR-MF-000023806
- Authorised Representative
- Diadent Europe B.V. NL-AR-000012597
Sources (2)
- EUDAMED e34c550f-32b0-43f5-9724-4d27149b8f63 61 fields · synced Jun 18, 2026
- FDA UDI b9172c92-5da6-497d-9aa7-2849b968519d 35 fields · synced May 30, 2026