Identity
- Trade Name
- SciPharm Glasion Glass IonomerCement FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restorations, permanent cementation of crowns and bridges, cementation of orthodontic bands, and lining of cavities. Liquid Bottle. Boxed. FDA UDI
- Model / Reference
- SP 51-022 B FDA UDI
- Description
- Glass Ionomer Restorative, Liner, and Cement whose application includes selected Class V restorations, permanent cementation of crowns and bridges, cementation of orthodontic bands, and lining of cavities. Liquid Bottle. Boxed. FDA UDI
Identifiers
- Catalog Number
- 51-022 FDA UDI
- Primary DI / UDI-DI
- D801SP51022B1 FDA UDI
- 510(k) Number
- K895386 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
Yes
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
Yes
FDA UDI
Category: Glass ionomer dental cement
SciPharm Glasion Glass IonomerCement by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glass ionomer dental cement.
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- KETAC™ — 3M COMPANY · Class II
- Ketac™ Cem radiopaque — 3M Deutschland GmbH · Class II
- Vitremer™ — 3M COMPANY · 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
- GC Fuji LINING™ — Gc America Inc. · Class II
Cleared under the same submission
K895386 also covers:
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
- MASTER-DENT — DENTONICS, INC.
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 |
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Manufacturer
- Manufacturer
- Scientific Pharmaceuticals, Inc.
Sources (1)
- FDA UDI 1310e0ca-4fa1-4f9c-b815-f7419535d5cd 37 fields · synced May 30, 2026