FDA UDI
In Commercial Distribution
🇺🇸 United States
DENTSPLY TruByte® Characterized Lucitone® Denture Base Resin
DI: D0026860431
·
Model: 686043
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DENTSPLY TruByte® Characterized Lucitone® Denture Base Resin
- Primary DI
- D0026860431
- Version / Model
- 686043
- Catalog Number
- 686043
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 844e7db5-7ce9-4d5d-b865-6e405164ea2e
Device Description
DENTSPLY TruByte® Characterized Lucitone® Denture Base Resin - Single Unit Packaging 50 Unit Pkg Reddish Pink
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16616 | Medicine bottle | An empty glass or plastic container, typically with a relatively narrow neck and a lid/cap, intended to be used to store medication so that it retains its viability. This is typically a single-patient device that is reused until the contents are exhausted. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D0026860431 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 21 | Gram | |
| Total Volume | 430 | Milliliter | |
| Device Size Text, specify | 50 Unit Powders, 1 Lab Liquid, 1 Standard Liquid, 2 Gingival Tone Powders |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from moisture and direct sunlight.
- Type
- Storage Environment Temperature
- Temperature Range
- 16 – 27 Degrees Celsius