Identity
- Trade Name
- MTA Firm- Normal Set FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- Endodontic repair cement - 0.25 g capsules FDA UDI
- Model / Reference
- ZEN-MTA-FRMNSET FDA UDI
- Description
- Endodontic repair cement - 0.25 g capsules FDA UDI
Identifiers
- Catalog Number
- ZEN-MTA-FRMNSET FDA UDI
- Primary DI / UDI-DI
- 17540208000407 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Endodontic filling/sealing material 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
Yes
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: Endodontic filling/sealing material
MTA Firm- Normal Set by Zendo Direct AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Zendo Direct AG
Sources (1)
- FDA UDI 6a5dc345-897b-40f2-af12-9523c50200b4 35 fields · synced May 29, 2026