FDA UDI
In Commercial Distribution
🇺🇸 United States
Lamineer Tips
DI: 07350081490485
·
Model: LTA/U
·
Dentatus AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lamineer Tips
- Primary DI
- 07350081490485
- Version / Model
- LTA/U
- Catalog Number
- LTA/U
- Company Name
- Dentatus AB
- Labeler DUNS
- 355803412
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-23
- Public Version
- 1
- Public Version Date
- 2025-01-31
- Public Version Status
- New
- Public Device Record Key
- 67974869-d4c8-462b-909e-e2d5b5694750
Device Description
Lamineer Tip Spatula & Knife Edge Assortment Pack - 20/Pack - Diamond Coated with Safe Side - LTA-15, LTA-30, LTA-39 x2, LTA-50 x2, LTA-75, LTA-100, LTA-150, LTA-S15, LTA-S30, LTA-S36 x2, LTA-S50 x2, LTA-S75, LTA-S100, LTA-S150, LTA-C50, LTA-E50
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EHL | Point, Abrasive | Dental | 872.6010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35807 | Dental abrasive disk, reusable | A dental instrument consisting of a circular flat or slightly conical sheet carrying or containing an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350081490485 | GS1 |