FDA UDI
In Commercial Distribution
🇺🇸 United States
IPR Lamineer Tips
DI: 07350081495640
·
Model: LTA-P/SK2
·
Dentatus AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IPR Lamineer Tips
- Primary DI
- 07350081495640
- Version / Model
- LTA-P/SK2
- Catalog Number
- LTA-P/SK2
- Company Name
- Dentatus AB
- Labeler DUNS
- 355803412
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-24
- Public Version
- 1
- Public Version Date
- 2024-11-01
- Public Version Status
- New
- Public Device Record Key
- 438f7224-70df-49ff-806f-02a9e8a7d04c
Device Description
5x Assorted Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 1 of each of the following: 0.1mm Blade Thickness, Double Sided 15 Micron Diamond Coating 0.2mm Blade Thickness, Double Sided 40 Micron Diamond Coating 0.3mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.4mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.5mm Blade Thickness, Double Sided 50 Micron Diamond Coating
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 |
|---|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44730 | Interproximal reduction kit | A collection of devices intended to be used for interproximal reduction (IPR), which is the reduction of contact between adjacent teeth during orthodontic alignment of the teeth. Fine abrasives are typically used to minimize pressure and allow the formation of spaces between the teeth, enabling more effective therapy without excessive interproximal contact, which may prolong or complicate teeth alignment. The device may include burs, abrasive disks, abrasive strips, thickness gauges and charts for tracking of reproximation. This device is reusable, but certain items will need to be replenished. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350081495640 | GS1 |