Identity
- Trade Name
- Pearson TempFill Material FDA UDI
- Generic Name
- Temporary dental filling material FDA UDI
- Device Name
- Pink X4 FDA UDI
- Model / Reference
- A590006 FDA UDI
- Description
- Pink X4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D724A5900061 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Temporary dental filling material 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Temporary dental filling material
Pearson TempFill Material by Pearson Dental Supplies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Temporary dental filling material.
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
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
- Pearson Dental Supplies, Inc.
Sources (1)
- FDA UDI fc3e6af0-8529-47e4-8a82-72d6c5cebe1a 33 fields · synced Jun 8, 2026