Identity
- Trade Name
- Hydroxyline FDA UDI
- Generic Name
- Dental cavity varnish FDA UDI
- Device Name
- HYDROXYLINE - Calcium Hydroxide Cavity Liner is a thin 'varnish' film that forms a chemical and physical barrier that seals tubules and protects the pulp from acids in cements and acid etching solutions. Use it under both temporary and permanent cementation to protect the pulp. It will prevent thermal and 'pulp' shock. FDA UDI
- Model / Reference
- Liquid Base - White - 6cc FDA UDI
- Description
- HYDROXYLINE - Calcium Hydroxide Cavity Liner is a thin 'varnish' film that forms a chemical and physical barrier that seals tubules and protects the pulp from acids in cements and acid etching solutions. Use it under both temporary and permanent cementation to protect the pulp. It will prevent thermal and 'pulp' shock. FDA UDI
Identifiers
- Catalog Number
- 05-2000 FDA UDI
- Primary DI / UDI-DI
- D8370520000 FDA UDI
- FDA Product Code
- EJK FDA UDI
- GMDN Term
- Dental cavity varnish FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3250 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 6 Milliliter FDA UDI
Category: Dental cavity varnish
Hydroxyline by Taub Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental cavity varnish.
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- NUPRO® — Dentsply Professional · Class II
- SciPharm Copal Cavity Varnish — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- SciPharm Fluoroseal Cavity Liner — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- NUPRO® — Dentsply Professional · Class II
- NUPRO® — Dentsply Professional · 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
- Taub Products
Sources (1)
- FDA UDI 11e7c72b-ce47-4003-83c7-729bdb8ee426 37 fields · synced Jun 8, 2026