Identity
- Trade Name
- SciPharm Luster Polishing Paste, Boxed FDA UDI
- Generic Name
- Dentifrice FDA UDI
- Device Name
- Dental Polishing Paste for Composite Restoratives, Amalgams, and Castings. FDA UDI
- Model / Reference
- SP 50-051 B FDA UDI
- Description
- Dental Polishing Paste for Composite Restoratives, Amalgams, and Castings. FDA UDI
Identifiers
- Catalog Number
- 50-051 FDA UDI
- Primary DI / UDI-DI
- D801SP50051B1 FDA UDI
- 510(k) Number
- K842403 FDA UDI
- FDA Product Code
- EJR FDA UDI
- GMDN Term
- Dentifrice 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: Dentifrice
SciPharm Luster Polishing Paste, Boxed by Scientific Pharmaceuticals, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dentifrice.
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
- Topex® Prophy Paste — Dentsply International · Class I
- Omni — Keystone Industries · Class I
- Disposable Prophy Angles, 105° Contra Angle Clear, Ribbed and Webbed — Premium Plus (Dongguan) Limited · Class IIa
- Dental City — ICP, INC. · Class I
- Blasting Powder — Bioclear Matrix Systems, LLC · Class I
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Prophy Brush — Huanghua Promisee Dental Co.Ltd. · Class I
Cleared under the same submission
K842403 also covers:
- MASTER-DENT — DENTONICS, INC.
- International Dental Supply Luster Polishing Paste — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Luster Polishing Paste — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Luster Polishing Paste, Non-Boxed — SCIENTIFIC PHARMACEUTICALS, INC.
- SciPharm Luster Polishing Paste, Spanish — SCIENTIFIC PHARMACEUTICALS, 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scientific Pharmaceuticals, Inc.
Sources (1)
- FDA UDI c5ab94f6-46e2-4773-8de4-a9b6eb46e395 37 fields · synced May 30, 2026