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Protech Glass Ion.cemkit-Intro 2-1210
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 740-0155
Identity
- Trade Name
- Protech FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- PROTECH GLASS ION.CEMKIT-INTRO 2-1210 EUDAMEDGlass Ionomer Band Cement Introductory Kit FDA UDI
- Model / Reference
- 740-0155 EUDAMEDFDA UDI
- Description
- Glass Ionomer Band Cement Introductory Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989075199 EUDAMED00889989080025 FDA UDI
- Basic UDI-DI
- B-00889989075199 EUDAMED
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Protech Glass Ion.cemkit-Intro 2-1210 by Ormco Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00889989075199 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (2)
- EUDAMED 3075ded9-49de-4326-ba6e-31b3d78d7467 61 fields · synced Jun 18, 2026
- FDA UDI 727a2845-3c41-4488-a741-d97263b55be9 35 fields · synced May 30, 2026