Identity
- Trade Name
- Parkell® EUDAMEDSmarTemp® FDA UDI
- Generic Name
- Dental material cartridge-plunging applicator, two-component, manual FDA UDI
- Device Name
- Dispensing Gun 3 EUDAMED10:1 50ml Split Cartridge Dispensing Gun for SmarTemp® X1 FDA UDI
- Model / Reference
- S349 EUDAMEDFDA UDI
- Description
- 10:1 50ml Split Cartridge Dispensing Gun for SmarTemp® X1 FDA UDI
Identifiers
- Catalog Number
- S349 FDA UDI
- Primary DI / UDI-DI
- 00810000528134 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000052MIXINGGUN3HU EUDAMED
- FDA Product Code
- EBG FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental material cartridge-plunging applicator, two-component, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Market of Registration
- Germany 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Parkell® by Parkell, Inc. — 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 | 081000052MIXINGGUN3HU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parkell Inc.
- EUDAMED SRN
- US-MF-000003761
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (2)
- EUDAMED 84e38559-05e8-4f25-b9dd-29975c47866e 61 fields · synced Jun 8, 2026
- FDA UDI 2f398ceb-dfb7-434b-baf4-61189991e1fe 35 fields · synced May 30, 2026