Identity
- Trade Name
- ProLube FDA UDI
- Generic Name
- Dental root surface conditioner FDA UDI
- Device Name
- Prolube: 100 count box FDA UDI
- Model / Reference
- PROLUBE100 FDA UDI
- Description
- Prolube: 100 count box FDA UDI
Identifiers
- Catalog Number
- PROLUBE100 FDA UDI
- Primary DI / UDI-DI
- D716PROLUBE1001 FDA UDI
- FDA Product Code
- EIC FDA UDI
- GMDN Term
- Dental root surface conditioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
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
No
FDA UDI
Category: Dental root surface conditioner
ProLube by Tulsa Dental Products Llc — 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
- Tulsa Dental Products Llc
Sources (1)
- FDA UDI 561146df-6bbf-4bcf-9269-0151858f0d26 34 fields · synced Jun 1, 2026