FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Characterized Lucitone®
DI: D0016863760
·
Model: 50-Unit Package
·
Dentsply International Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Characterized Lucitone®
- Primary DI
- D0016863760
- Version / Model
- 50-Unit Package
- Catalog Number
- 686376
- Company Name
- Dentsply International Inc.
- Labeler DUNS
- 606173334
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-10
- Public Version
- 5
- Public Version Date
- 2022-05-06
- Public Version Status
- Update
- Public Device Record Key
- 83249c89-c860-4718-b135-e49dee4396a7
- Distribution End Date
- 2022-05-05
Device Description
Light. Contains fifty (50) 21 gram packages of Characterized Lucitone Powder, one (1) 430 milliliter bottle of Lucitone Liquid, one (1) 120 milliliter bottle of Lucitone Liquid, and two (2) 10 gram bottles of Gingival Tone Powder
Device Characteristics
- Single Use
- No
- 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
- 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 |
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 | D0016863760 | HIBCC |
Customer Contacts
- Phone
- +1(800)243-1942 ext. 54660
- [email protected]