Identity
- Trade Name
- Plastic Pipettes 1ml EUDAMEDPLASTIC PIPETTES 1mL - 25 pieces FDA UDI
- Generic Name
- Dental irrigation/aspiration syringe FDA UDI
- Device Name
- Plastic Pipettes EUDAMEDPLASTIC PIPETTES 1mL - 25 pieces One assortment of 5 color-coded pipette For introducing solutions into the root canal or cavities FDA UDI
- Model / Reference
- 11757 EUDAMED11752 FDA UDI
- Description
- PLASTIC PIPETTES 1mL - 25 pieces One assortment of 5 color-coded pipette For introducing solutions into the root canal or cavities FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640159161585 EUDAMEDFDA UDI
- Basic UDI-DI
- 764015916PIPETTESB4 EUDAMED
- FDA Product Code
- EIC FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental irrigation/aspiration syringe FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not 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
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
Plastic Pipettes 1ml by Produits Dentaires SA — 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 | 764015916PIPETTESB4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Produits Dentaires SA
- EUDAMED SRN
- CH-MF-000023147
- Authorised Representative
- PD DENTAL EU SAS FR-AR-000017144
Sources (2)
- EUDAMED 6961102a-c937-4144-a534-d0c9b8f382ea 61 fields · synced Jul 15, 2026
- FDA UDI e133f06a-3a76-4520-8c80-4eb950a1548d 35 fields · synced May 29, 2026