Identity
- Trade Name
- PRECI-POST SET EUDAMEDCEKA & PRECI-LINE ATTACHMENTS FDA UDI
- Generic Name
- Steel dental bur, reusable FDA UDI
- Device Name
- PRECI-POST M SET EUDAMEDPRECI-POST SET FDA UDI
- Model / Reference
- 2001 EUDAMEDFDA UDI
- Description
- PRECI-POST SET FDA UDI
Identifiers
- Catalog Number
- 2001 FDA UDI
- Primary DI / UDI-DI
- 04260576941411 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260576942001YQ EUDAMED
- Direct Marketing DI
- 04260576941411 EUDAMED
- FDA Product Code
- EGG FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Steel dental bur, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3165 FDA UDI
- Market of Registration
- Belgium 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.8 Millimeter FDA UDI
Preci-Post Set by Alphadent NV — 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 | 4260576942001YQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alphadent NV
- EUDAMED SRN
- BE-MF-000000923
Sources (2)
- EUDAMED a2bb7da9-1ce7-475d-9094-b45f079bba78 61 fields · synced Jun 19, 2026
- FDA UDI 934626aa-701c-49b4-90a1-82b7c20c3ce7 36 fields · synced May 30, 2026