Identity
- Trade Name
- Hu-Friedy EUDAMEDFDA UDI
- Generic Name
- Manual endodontic filling material spreader FDA UDI
- Device Name
- #D11T SE Root Canal Spreader, Black Line FDA UDI
- Model / Reference
- Dental Intruments EUDAMEDRCSD11TX EUDAMEDFDA UDI
- Description
- #D11T SE Root Canal Spreader, Black Line FDA UDI
Identifiers
- Catalog Number
- RCSD11TX FDA UDI
- Primary DI / UDI-DI
- 10889950105488 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889950Place1R5C EUDAMED
- FDA Product Code
- EKK FDA UDI
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED
- GMDN Term
- Manual endodontic filling material spreader FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Category: Calcium hydroxide dental cement
Hu-Friedy by Hu-Friedy Manufacturing Co., LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Calcium hydroxide dental cement.
- AxioPro ART — Axiodent Inc. · Class II
- Calcimol LC — VOCO GmbH · Class II
- ADSEAL — Meta Biomed Co., Ltd. · Class IIa
- Cerafill RCS — PREVEST DENPRO LIMITED · Class II
- Endoseal — PREVEST DENPRO LIMITED · Class II
- Cerafill Putty — PREVEST DENPRO LIMITED · Class IIa
- Calplus — PREVEST DENPRO LIMITED · Class II
- Calplus — PREVEST DENPRO LIMITED · Class II
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 | 0889950Place1R5C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hu-Friedy Manufacturing Co., LLC
- EUDAMED SRN
- US-MF-000017104
- Authorised Representative
- Hu-Friedy Europe LLC & Co. KG DE-AR-000005530
Sources (2)
- EUDAMED 97842e91-1037-425c-96af-ef3062894596 61 fields · synced Jul 12, 2026
- FDA UDI f0ff959b-1394-4ae2-b969-0a7d54633e55 35 fields · synced May 29, 2026