Identity
- Trade Name
- Dentsply Sirona FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- Gutta Smart TM FDA UDI
- Model / Reference
- AEU-65-DS FDA UDI
- Description
- Gutta Smart TM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10817417020166 FDA UDI
- FDA Product Code
- EKM FDA UDI
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3850 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endodontic obturation system
Dentsply Sirona by Aseptico, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Endodontic obturation system.
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- EVOFILL DUO — DiaDent Group International · Class I
- EVOFILL DUO — DiaDent Group International · Class I
- DUO-PEN — DiaDent Group International · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aseptico, Inc.
Sources (2)
- FDA UDI bbb51342-0eda-4913-b8fe-25cfd519f9d6 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026