Identity
- Trade Name
- UniCore Post System Size 1 EUDAMEDUniCore FDA UDI
- Generic Name
- Root canal post, preformed FDA UDI
- Device Name
- Unicore Post EUDAMEDUniCore Post Size #1 Refill FDA UDI
- Model / Reference
- 7125 EUDAMEDFDA UDI
- Description
- UniCore Post Size #1 Refill FDA UDI
Identifiers
- Catalog Number
- 7125 FDA UDI
- Primary DI / UDI-DI
- 00883205003836 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF119B5 EUDAMED
- FDA Product Code
- ELR FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS 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
Yes
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
Category: Root canal post, preformed
UniCore by Ultradent Products, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Root canal post, preformed.
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- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
Sources (2)
- FDA UDI 2a6eb8ba-026e-48bf-80d6-ce27d2bc9818 35 fields · synced Jul 22, 2026
- EUDAMED 113ff363-0aea-4a11-b493-d1f276662a57 61 fields · synced Jul 22, 2026