Identity
- Trade Name
- EndoCeramic Root Repair Material FDA UDI
- Generic Name
- Root canal obturation kit FDA UDI
- Model / Reference
- ECRRM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810138823238 FDA UDI
- 510(k) Number
- K241457 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Root canal obturation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3820 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Root canal obturation kit
EndoCeramic Root Repair Material by Endo Direct, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Friendo — DXM CO., LTD · Class I
- EndoCeramic Sealer — ENDO DIRECT, LLC · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Endo Direct, Llc
Sources (1)
- FDA UDI 9e363651-09f1-4319-8b95-5d1b8db44f2c 34 fields · synced Jun 6, 2026