Identity
- Trade Name
- TORQUEMASTER 5 4-HOLE FDA UDI
- Generic Name
- Dental surgical power tool motor, pneumatic FDA UDI
- Device Name
- THE TORQUEMASTER 5 4-HOLE IS AN ADJUSTABLE SPEED UP TO 5000 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 FDA UDI
- Model / Reference
- LXTM54 FDA UDI
- Description
- THE TORQUEMASTER 5 4-HOLE IS AN ADJUSTABLE SPEED UP TO 5000 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D826LXTM54 FDA UDI
- 510(k) Number
- K940261 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental surgical power tool motor, pneumatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental surgical power tool motor, pneumatic
Torquemaster 5 4-Hole by Mti Precision Products — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental surgical power tool motor, pneumatic.
- AM-20 SD RQ Airmotor — W & H Dentalwerk Bürmoos GmbH · Class I
- AM-25 RQ Airmotor — W & H Dentalwerk Bürmoos GmbH · Class I
- MK-dent — MK-Dent GmbH · Class I
- AM-20 E RM — W & H Dentalwerk Bürmoos GmbH · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- SABLE - Hygienist Package — Sable Industries Inc · Class I
- SABLE - Hygienist Package — Sable Industries Inc · Class I
- TA Bulb — NAKANISHI INC. · Class I
Cleared under the same submission
K940261 also covers:
- LYNX 4:1 REDUCTION CONTRA ANGLE — MTI PRECISION PRODUCTS
- LYNX 4:1 REDUCTION NOSECONE — MTI PRECISION PRODUCTS
- LYNX CLASSIC MOTOR — MTI PRECISION PRODUCTS
- LYNX LONG BLUE NOSECONE — MTI PRECISION PRODUCTS
- LYNX SHORT BLUE NOSECONE — MTI PRECISION PRODUCTS
- MASTER TORQUEMASTER 5 — MTI PRECISION PRODUCTS
- PHOPHY AIRLITE 4-HOLE — MTI PRECISION PRODUCTS
- PROPHY AIRLITE 4-HOLE — MTI PRECISION PRODUCTS
- PROPHY AIRLITE 4-HOLE — MTI PRECISION PRODUCTS
- TORQUEMASTER 5 2-HOLE — MTI PRECISION PRODUCTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mti Precision Products
Sources (1)
- FDA UDI 02f0af12-93f1-47f3-aa3a-98b038e438ef 34 fields · synced May 29, 2026