Identity
- Trade Name
- PROCEM FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- Procem Cement - Grace Medical FDA UDI
- Model / Reference
- 986-001 FDA UDI
- Description
- Procem Cement - Grace Medical FDA UDI
Identifiers
- Catalog Number
- 986-001 FDA UDI
- Primary DI / UDI-DI
- M7379860011 FDA UDI
- 510(k) Number
- K140644 FDA UDI
- FDA Product Code
- NEA 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Procem by Ototronix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K140644 also covers:
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
- Ototronix, LLC
Sources (1)
- FDA UDI 37af3da5-6022-46ef-973f-11b2745b9b25 35 fields · synced Jun 7, 2026