FDA UDI
In Commercial Distribution
🇺🇸 United States
Smoothdrive
DI: D950135110
·
Model: Motor Control System with Fluoresce HD
·
LARES RESEARCH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Smoothdrive
- Primary DI
- D950135110
- Version / Model
- Motor Control System with Fluoresce HD
- Catalog Number
- 13511
- Company Name
- LARES RESEARCH
- Labeler DUNS
- 009127838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-01
- Public Version
- 1
- Public Version Date
- 2025-09-09
- Public Version Status
- New
- Public Device Record Key
- a7e8cdbc-23e6-41ba-a636-63a6617c8773
Device Description
Smoothdrive electric dental motor control system with Fluoresce HD motor
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EIA | Unit, Operative Dental | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41264 | Surgical power tool system control unit, line-powered | A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D950135110 | HIBCC |
Customer Contacts
- Phone
- 5303451767
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220873 | 000 |