Identity
- Trade Name
- Mixing Wells FDA UDI
- Generic Name
- Dental material mixing surface, chairside, single-use FDA UDI
- Device Name
- Mixing Wells EUDAMEDDisposable. 4-well configuration (420/box) FDA UDI
- Model / Reference
- MW-4 EUDAMEDFDA UDI
- Description
- Disposable. 4-well configuration (420/box) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701MW42 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D701MWB3 EUDAMED
- Unit of Use DI
- D701MW41 EUDAMED
- FDA Product Code
- JDZ FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental material mixing surface, chairside, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4210 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Mixing Wells by Pulpdent Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D701MWB3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- EUDAMED SRN
- US-MF-000004897
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 78193f7a-28ed-4e4b-9d82-b24bd0e214af 61 fields · synced Jul 12, 2026
- FDA UDI 8d9b6e0c-26ba-4abd-b79f-6a7f916a0ab3 33 fields · synced May 29, 2026