Identity
- Trade Name
- BISICO Glass Cem FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- Glass ionomer luting cement, suitable for cementing crowns, bridges, inlays and onlays. Is used in dentistry. FDA UDI
- Model / Reference
- 75060 FDA UDI
- Description
- Glass ionomer luting cement, suitable for cementing crowns, bridges, inlays and onlays. Is used in dentistry. FDA UDI
Identifiers
- Catalog Number
- 75060 FDA UDI
- Primary DI / UDI-DI
- EBIB750601 FDA UDI
- 510(k) Number
- K011431 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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
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
BISICO Glass Cem by bisico Bielefelder Dentalsilicone GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glass ionomer dental cement.
- 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
- GC Fuji II LC® — Gc America Inc. · Class II
Cleared under the same submission
K011431 also covers:
- Glidewell RMGI Cement — PRISMATIK DENTALCRAFT, INC.
- Glidewell RMGI Cement — PRISMATIK DENTALCRAFT, INC.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- bisico Bielefelder Dentalsilicone GmbH & Co. KG
Sources (1)
- FDA UDI 2b77dced-a3cb-43ff-bb0a-b3f59b0afbcb 37 fields · synced May 30, 2026