Identity
- Trade Name
- NORDENT MANUFACTURING INC FDA UDI
- Generic Name
- Endodontic filling material condenser FDA UDI
- Device Name
- ENDODONTIC CONDENSER DE #9-11 FDA UDI
- Model / Reference
- CEEN9-11 FDA UDI
- Description
- ENDODONTIC CONDENSER DE #9-11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840018633193 FDA UDI
- FDA Product Code
- EKT FDA UDI
- GMDN Term
- Endodontic filling material condenser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Category: Endodontic filling material condenser
NORDENT MANUFACTURING INC Endodontic Condenser, a precision dental instrument that uses heat to condense endodontic filling material in root canals. This reusable device is designed for implantable procedures and comes with a single use model.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nordent Manufacturing Inc
Sources (1)
- FDA UDI 139546d9-ecaa-4326-9ed0-177fa5a2dbc4 33 fields · synced Jul 18, 2026