FDA UDI
In Commercial Distribution
🇺🇸 United States
LYNX CLASSIC MOTOR
DI: D826LX100B2
·
Model: LX100B2H
·
MTI Precision Products, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LYNX CLASSIC MOTOR
- Primary DI
- D826LX100B2
- Version / Model
- LX100B2H
- Company Name
- MTI Precision Products, LLC
- Labeler DUNS
- 081600128
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-10
- Public Version
- 1
- Public Version Date
- 2023-02-20
- Public Version Status
- New
- Public Device Record Key
- d7ae1d3f-3205-447d-b8fa-5695a443693e
Device Description
LYNX ETYPE 20000 RPM 4 HOLE LOW SPEED PNEUMATIC DENTAL MOTOR, USED IN CONJUNCTION WITH OTHER ATTACHMENTS AND CONNECTS TO THE OPERATORY TO DRILL BONE, TEETH AND TOUGH TISSUES IN A DENTAL SETTING.
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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66228 | Dental surgical power tool motor, pneumatic | A hand-held, pneumatically-powered component of a surgical power tool assembly designed to convert the energy from a compressed gas source [e.g., surgical-grade air or nitrogen (N2)] into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | D826LX100B20 | HIBCC | ||||
| Primary | D826LX100B2 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K895736 | 000 |