Identity
- Trade Name
- tubliCEM - Root Canal Sealant 8g/3.5g EUDAMED
- Device Name
- Epoxy Resin Root Canal Sealer Paste / ZOE endodontic cement EUDAMED
- Model / Reference
- AH0770 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060446603321 EUDAMED
- Basic UDI-DI
- 5056009120138SH EUDAMED
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Calcium hydroxide dental cement
tubliCEM - Root Canal Sealant 8g/3.5g by Advanced Healthcare Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Calcium hydroxide dental cement.
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- AxioPro ART — Axiodent Inc. · Class II
- Calcimol LC — VOCO GmbH · Class II
- ADSEAL — Meta Biomed Co., Ltd. · Class IIa
- Cerafill RCS — PREVEST DENPRO LIMITED · Class II
- Endoseal — PREVEST DENPRO LIMITED · Class II
- Cerafill Putty — PREVEST DENPRO LIMITED · Class IIa
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5056009120138SH | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Healthcare Ltd.
- EUDAMED SRN
- GB-MF-000002771
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED f7f27d90-1209-40d9-acdd-9311defa3a1c 61 fields · synced Jul 11, 2026