FDA UDI
In Commercial Distribution
🇺🇸 United States
TORQUEMASTER 20 4HOLE
DI: D826TM204
·
Model: TM204
·
MTI Precision Products, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- TORQUEMASTER 20 4HOLE
- Primary DI
- D826TM204
- Version / Model
- TM204
- 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
- e6e9fdf3-2d78-4635-93a3-3abae2e94ed9
Device Description
TORQUE MASTER 20 4-HOLE IS AN ADJUSTABLE SPEED UP TO 20000 RPM LOW SPEED PNEUMATIC DENTAL MOTOR, USED IN CONJUNCTION WITH OTHER ATTACHMENTS SUCH AS BURS AND MANDRELS WHICH CONNECTS TO AN OPERATORY TO DRILL BONE, TEETH AND TOUGH TISSUES IN A DENTAL SETTING. REMOVING CALCULUS AND POLISHING TEEETH
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| 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 | D826TM2040 | HIBCC | ||||
| Primary | D826TM204 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K895736 | 000 |