Identity
- Trade Name
- Glidewell RMGI Cement FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- Glidewell RMGI cement 1X0.4gm FDA UDI
- Model / Reference
- 70-1198-PVC0001 FDA UDI
- Description
- Glidewell RMGI cement 1X0.4gm FDA UDI
Identifiers
- Catalog Number
- 70-1198-PVC00010 FDA UDI
- Primary DI / UDI-DI
- D745701198PVC00010 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
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
No
FDA UDI
Category: Glass ionomer dental cement
Glidewell RMGI Cement by Prismatik Dentalcraft, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K011431 also covers:
- 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
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA UDI a45321a9-73be-48d0-bee5-ed8f53edb33c 36 fields · synced May 30, 2026