FDA UDI
In Commercial Distribution
🇺🇸 United States
Ti-Core Auto
DI: 00766054000044
·
Model: 830-00
·
ESSENTIAL DENTAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ti-Core Auto
- Primary DI
- 00766054000044
- Version / Model
- 830-00
- Catalog Number
- 830-00
- Company Name
- ESSENTIAL DENTAL SYSTEMS, INC.
- Labeler DUNS
- 101147171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-01
- Public Version
- 4
- Public Version Date
- 2023-11-22
- Public Version Status
- Update
- Public Device Record Key
- edce0889-b318-46ae-a98d-8bfc74814dc9
Device Description
Core Material Syringeable Dual Cure Natural Shade A2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMA | CEMENT, DENTAL | Dental | 872.3275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47906 | Custom-made dental composite resin kit | A collection of customized equipment and supplies intended to be used to apply/polymerize composite resins to fill dental cavities or restore damaged dental tissue. It includes the composite resin, which may be self-, light-, or dual-cured, and additional devices which typically include a dental syringe, a mixing palette, a mixing pad, and brushes; it is customized for a specific patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00766054000044 | GS1 |
Customer Contacts
- Phone
- +1(201)487-9090
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101504 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Two - 9.5 gram dual barrel syringes |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 60 – 85 Degrees Fahrenheit