Hydroxyline
- Primary DI
- D8370510000
- Brand
- Hydroxyline
- Company
- Taub Products
- Model
- Kit - White
- Catalog number
- 05-1000
- Device 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.
- Published
- 2016-10-26
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| EJK | Liner, Cavity, Calcium Hydroxide |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D8370510000 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental cavity varnish | A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused. |
Device Sizes
| Type | Value | Unit |
|---|
| Total Volume | 6 | Milliliter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Keep away from open flame. See SDS. |
Regulatory Flags
- DUNS number
- 067488114
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| D8375210050 | ENERGY CTZ1 CEMENT | WHITE - 5.4ML SYR | 52-1005 | 2025-07-14 |
| D8375210000 | ENERGY CTZ1 CEMENT | CLEAR - 5ML SYR | 52-1000 | 2023-11-02 |
| D8375210100 | ENERGY CTZ1 CEMENT | WHITE A2 - 5ML SYR | 52-1010 | 2023-11-02 |
| D8375210500 | ENERGY CTZ3 CEMENT | CLEAR - 5ML SYR | 52-1050 | 2023-11-02 |
| D8375210600 | ENERGY CTZ3 CEMENT | WHITE A2 - 5ML SYR | 52-1060 | 2023-11-02 |
| D8370710000 | Tru-Paque | Kit - 12 mL - Standard - Lt.Cream; Dk Yellow; Gray | 07-1000 | 2023-06-26 |
| D8370710010 | Tru-Paque | Kit - 12 mL - Special Color | 07-1001 | 2023-06-26 |
| D8370720000 | Tru-Paque | Light Cream - 12 mL | 07-2000 | 2023-06-26 |
| D8370720010 | Tru-Paque | Light Cream - 50 mL | 07-2001 | 2023-06-26 |
| D8370720100 | Tru-Paque | Light Yellow - 12 mL | 07-2010 | 2023-06-26 |
| D8370720110 | Tru-Paque | Light Yellow - 50 mL | 07-2011 | 2023-06-26 |
| D8370720200 | Tru-Paque | Tan - 12 mL | 07-2020 | 2023-06-26 |
| D8370720210 | Tru-Paque | Tan - 50 mL | 07-2021 | 2023-06-26 |
| D8370720300 | Tru-Paque | Dark Yellow - 12 mL | 07-2030 | 2023-06-26 |
| D8370720310 | Tru-Paque | Dark Yellow - 50 mL | 07-2031 | 2023-06-26 |
| D8370720400 | Tru-Paque | Gray - 12 mL | 07-2040 | 2023-06-26 |
| D8370720410 | Tru-Paque | Gray - 50 mL | 07-2041 | 2023-06-26 |
| D8370720500 | Tru-Paque | White - 12 mL | 07-2050 | 2023-06-26 |
| D8370720510 | Tru-Paque | White - 50 mL | 07-2051 | 2023-06-26 |
| D8370720600 | Tru-Paque | Pink Blend - 12 mL | 07-2060 | 2023-06-26 |
Other Devices Sharing Product Codes
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