Identity
- Trade Name
- SciPharm Diamond Luster Polishing Paste FDA UDI
- Generic Name
- Professional dental abrasive material FDA UDI
- Device Name
- Diamond Luster Polishing Paste Syringe for Dental Ceramics. Unlabeled 2 gram syringe. FDA UDI
- Model / Reference
- SP 55-05 U2G FDA UDI
- Description
- Diamond Luster Polishing Paste Syringe for Dental Ceramics. Unlabeled 2 gram syringe. FDA UDI
Identifiers
- Catalog Number
- 55-05 FDA UDI
- Primary DI / UDI-DI
- D801SP5505U2G1 FDA UDI
- 510(k) Number
- K873686 FDA UDI
- FDA Product Code
- EJR FDA UDI
- GMDN Term
- Professional dental abrasive material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6030 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: Professional dental abrasive material
SciPharm Diamond Luster Polishing Paste by Scientific Pharmaceuticals, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 I | Pending data |
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Manufacturer
- Manufacturer
- Scientific Pharmaceuticals, Inc.
Sources (1)
- FDA UDI 179554e7-84c1-468e-926a-80cae09ff505 37 fields · synced May 30, 2026