FDA UDI
In Commercial Distribution
🇺🇸 United States
D-Fine Double Diamond™ Final High Shine Refill #03
DI: 00359883003678
·
Model: 132503
·
DEN-MAT HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- D-Fine Double Diamond™ Final High Shine Refill #03
- Primary DI
- 00359883003678
- Version / Model
- 132503
- Catalog Number
- 132503
- Company Name
- DEN-MAT HOLDINGS, LLC
- Labeler DUNS
- 809857704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-12
- Public Version
- 1
- Public Version Date
- 2025-03-20
- Public Version Status
- New
- Public Device Record Key
- 709152a0-ccd2-4046-831a-50f02983a405
Device Description
Dental burnisher
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJR | AGENT, POLISHING, ABRASIVE, ORAL CAVITY | Dental | 872.6030 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31833 | Dental abrasive point, reusable | A rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00359883003678 | GS1 |
Customer Contacts
- Phone
- +1(800)433-6628
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature