Identity
- Trade Name
- AH Plus EUDAMEDAH PLUS ROOTCANAL FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- AH Plus EUDAMEDAH Plus Refill Kit is a two-component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Root Canal Sealer in tubes for manual mixing of Paste A + B (D010K3018020 and D010K3018030). With its supporting accessory (Mixing Pad) it can be classified as a convenience kit. FDA UDI
- Model / Reference
- 60620110 EUDAMEDFDA UDI
- Description
- AH Plus Refill Kit is a two-component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Root Canal Sealer in tubes for manual mixing of Paste A + B (D010K3018020 and D010K3018030). With its supporting accessory (Mixing Pad) it can be classified as a convenience kit. FDA UDI
Identifiers
- Catalog Number
- 60620110 FDA UDI
- Primary DI / UDI-DI
- D010606201101 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D010EFM02PZ EUDAMED
- FDA Product Code
- KIF FDA UDI
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED
- GMDN Term
- Endodontic filling/sealing material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3820 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 4 Milliliter FDA UDI
Category: Calcium hydroxide dental cement
AH Plus by Dentsply DeTrey GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D010EFM02PZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Dentsply DeTrey GmbH
- EUDAMED SRN
- DE-MF-000005905
Sources (2)
- EUDAMED 90fd1e47-0bd9-4c8b-86f5-c43b86152700 61 fields · synced Aug 1, 2026
- FDA UDI c9e87367-13b3-4268-a83d-6ff3ca0aa354 36 fields · synced May 30, 2026