← Back to catalogue
Harvard Ionoglas Cem Extra OptiCaps, Shade Universal
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 7042250
Identity
- Trade Name
- Harvard Ionoglas Cem Extra OptiCaps, Shade Universal FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- GLMGIC500 EUDAMEDEsthetic glass ionomer cement for luting and lining FDA UDI
- Model / Reference
- 7042250 EUDAMEDFDA UDI
- Description
- Esthetic glass ionomer cement for luting and lining FDA UDI
Identifiers
- Primary DI / UDI-DI
- +EHAR7042250 EUDAMEDEHAR70422501 FDA UDI
- Basic UDI-DI
- ++EHARGLMGIC500Y8 EUDAMED
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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: Glass ionomer dental cement
Harvard Ionoglas Cem Extra OptiCaps, Shade Universal by Harvard Dental International GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Glass ionomer dental cement.
- Medental Glass Ionomer Type II Restorative — CONAMCO S.A. DE C.V. dba Medental · Class IIa
- 3M™ Ketac™ Fil Plus Aplicap™ — 3M Deutschland GmbH · Class II
- KETAC™ — 3M COMPANY · Class II
- Ketac™ Cem radiopaque — 3M Deutschland GmbH · Class II
- Vitremer™ — 3M COMPANY · Class II
- SciPharm Until Temporary Crown and Bridge Cement — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- Precedent — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
- Vivid Glass Restorative A2 Std Pkg — PEARSON DENTAL SUPPLIES, INC. · Class II
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Harvard Dental International GmbH
Sources (2)
- FDA UDI f9439f53-ce12-44ae-9305-49e60919e907 35 fields · synced Oct 7, 2026
- EUDAMED 7d98ccce-88b8-4486-9828-4e5fd1ce9d1f 61 fields · synced Oct 7, 2026