Identity
- Trade Name
- Pi-Ku-Plast HP 36 monomer, FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Pi-Ku-Plast HP 36 monomer, yellow 100 ml FDA UDI
- Model / Reference
- 54000211 FDA UDI
- Description
- Pi-Ku-Plast HP 36 monomer, yellow 100 ml FDA UDI
Identifiers
- Catalog Number
- 54000211 FDA UDI
- Primary DI / UDI-DI
- EBRE540002110 FDA UDI
- FDA Product Code
- EGD FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
Pi-Ku-Plast HP 36 monomer, by bredent GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- bredent GmbH & Co. KG
Sources (1)
- FDA UDI 339b546b-8c5b-40a7-976d-995e2209b884 36 fields · synced May 31, 2026