FDA UDI
In Commercial Distribution
🇺🇸 United States
Hydroxyline
DI: D8370510000
·
Model: Kit - White
·
Taub Products
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hydroxyline
- Primary DI
- D8370510000
- Version / Model
- Kit - White
- Catalog Number
- 05-1000
- Company Name
- Taub Products
- Labeler DUNS
- 067488114
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-26
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 9f16e7ef-f5ed-4874-a4f1-102e707df66f
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | 872.3250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35698 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D8370510000 | HIBCC |
Customer Contacts
- Phone
- +1.201.798.5353
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 6 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from open flame. See SDS.