FDA UDI
In Commercial Distribution
🇺🇸 United States
LYNX 4:1 REDUCTION CONTRA ANGLE
DI: D826LX10104
·
Model: LX101
·
MTI Precision Products, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LYNX 4:1 REDUCTION CONTRA ANGLE
- Primary DI
- D826LX10104
- Version / Model
- LX101
- 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
- d4c62cf8-64fc-42f2-a0e8-f97508c8c2fa
Device Description
LYNX REDUCTION CONTRA ANGLE IS A LOWSPEED DENTAL HANDPIECE ATTACHMENT WHICH ACCEPTS DIFFERENT STYLES OF LATCH HEADS, PROPHY HEADS,SPRING AND FRICTION GRIP. WHICH WORK TOGETHER WITH AN E-TYPE MOTOR AS A 4:1 TRANSMISSION FROM THE MOTOR TO THE HEAD INCREASING THE TORQUE AND SLOWING THE MOTOR DOWN TO 1/4 IT'S SPEED. IT IS USED FOR THE POLISHING OF TEETH AND REMOVAL OF CARRIES 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
- 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 |
|---|---|---|---|---|
| 66247 | Dental power tool handpiece motorless component | A component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | D826LX101040 | HIBCC | ||||
| Primary | D826LX10104 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K940261 | 000 |