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25 ParaPost XH Titanium Posts (.045" / 1.14mm)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P8845B
Identity
- Trade Name
- 25 ParaPost XH Titanium Posts (.045" / 1.14mm) EUDAMEDParaPost XH FDA UDI
- Generic Name
- Root canal post, preformed FDA UDI
- Device Name
- ParaPost XH EUDAMED25 ParaPost XH Titanium Posts - .045 FDA UDI
- Model / Reference
- P8845B EUDAMEDFDA UDI
- Description
- 25 ParaPost XH Titanium Posts - .045 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661P8845B1 EUDAMEDFDA UDI
- Basic UDI-DI
- B-D661P8845B1 EUDAMED
- FDA Product Code
- ELR FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Root canal post, preformed FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3810 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
25 ParaPost XH Titanium Posts (.045" / 1.14mm) by Coltene/Whaledent Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-D661P8845B1 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (2)
- EUDAMED 885b7ad2-c4a6-4764-95ae-69912d04613b 61 fields · synced Jun 18, 2026
- FDA UDI d8b59978-03e4-43ad-93ca-be955d67bf29 33 fields · synced May 30, 2026