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25 ParaPost XP Stainless Steel Posts (.036" / 0.90mm)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P7443B
Identity
- Trade Name
- 25 ParaPost XP Stainless Steel Posts (.036" / 0.90mm) EUDAMEDParaPost XP FDA UDI
- Generic Name
- Root canal post, preformed FDA UDI
- Device Name
- ParaPost XP EUDAMED25 ParaPost XP SS Posts - .036 FDA UDI
- Model / Reference
- P7443B EUDAMEDFDA UDI
- Description
- 25 ParaPost XP SS Posts - .036 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661P7443B1 EUDAMEDFDA UDI
- Basic UDI-DI
- B-D661P7443B1 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 XP Stainless Steel Posts (.036" / 0.90mm) 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-D661P7443B1 | 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 337bf8f2-e72e-47cf-8337-1ca029b92724 61 fields · synced Jun 19, 2026
- FDA UDI d010e760-2a38-4ae9-86d8-a40af5b5e70a 33 fields · synced May 30, 2026