FDA UDI
In Commercial Distribution
🇺🇸 United States
Ti-Core Gray Fast Set
DI: 00766054000013
·
Model: 805-00
·
ESSENTIAL DENTAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ti-Core Gray Fast Set
- Primary DI
- 00766054000013
- Version / Model
- 805-00
- Catalog Number
- 805-00
- 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
- f0f1006a-b166-4884-9a86-2dd7192a9097
Device Description
Core Material Paste/Paste Chemical Cure Gray Shade Fast Set
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 |
|---|---|---|---|---|
| EBF | MATERIAL, TOOTH SHADE, RESIN | Dental | 872.3690 | 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 | 00766054000013 | GS1 |
Customer Contacts
- Phone
- +1(201)487-9090
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K922252 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | One 15 gram Jar Base and One 15 gram Jar Catalyst |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 60 – 85 Degrees Fahrenheit