Identity
- Trade Name
- EndoCeramic Sealer FDA UDI
- Generic Name
- Root canal obturation kit FDA UDI
- Model / Reference
- ECS2G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810138822651 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 Sealer by Endo Direct, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Root canal obturation kit.
- RE-GEN Bioactive EndoPutty Kit — Vista Dental · Class II
- Endo@pex — DXM CO., LTD · Class I
- Gutta Easy — DXM CO., LTD · Class I
- RE-GEN Bioactive EndoSealer — Vista Dental · Class II
- REGEN Bioactive EndoSealer (SS MST Kit) — Vista Dental · Class II
- Friendo — DXM CO., LTD · Class I
- EndoCeramic Root Repair Material — 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 6e46f5d4-c5f1-4c20-9c83-e4e1e9114a76 33 fields · synced Jun 8, 2026