FDA UDI
In Commercial Distribution
🇺🇸 United States
Lucitone Digital Fuse™
DI: D0019061850
·
Model: Step 1 - 3D Tooth Conditioning Agent
·
Dentsply International Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Lucitone Digital Fuse™
- Primary DI
- D0019061850
- Version / Model
- Step 1 - 3D Tooth Conditioning Agent
- Catalog Number
- 906185
- Company Name
- Dentsply International Inc.
- Labeler DUNS
- 606173334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-09
- Public Version
- 2
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 6acfb9a4-3dbb-4535-9955-15d02be226ca
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
- No
- 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 |
|---|---|---|---|---|
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | Dental | 872.3760 | 2 |
| EBD | Coating, filling material, resin | Dental | 872.3310 | 2 |
| KLE | AGENT, TOOTH BONDING, RESIN | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16730 | Dental appliance fabrication material, resin | A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D0019061850 | HIBCC |
Customer Contacts
- Phone
- +1(800)243-1942 ext. 54660
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 180 | Gram |