FDA.reportPublic FDA data

TORQUEMASTER 20 2-HOLE

Primary DI
D826TM202
Brand
TORQUEMASTER 20 2-HOLE
Company
MTI Precision Products, LLC
Model
TM202
Device description
TORQUE MASTER 20 2-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
Published
2023-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895736000LYNX-HIGH SPEED HANDPIECEMti Precision Products1989-12-18EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D826TM2020Direct MarkingHIBCC0
D826TM202PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motor, pneumaticA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081600128
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8265007703LYNX MASTER CLASSIC M0TOR 50077-032023-02-10
D8265008703LYNX MASTER CLASSIC MOTOR50087-032023-02-10
D8265013503MASTER SWIVEL LYNX CLASSIC MOTOR50135032023-02-10
D8265013604MASTER TORQUEMASTER 550136042023-02-10
D8265015403MASTER PROPHY AIRLITE50154-032023-02-10
D8265015406MASTER PROPHY AIRLITE50154-062023-02-10
D8265015408MASTER PROPHY AIRLITE50154-082023-02-10
D8265016304MASTER PRO 550163-042023-02-10
D8265025003PROPHY AIRLITE 4-HOLE50250032023-02-10
D8265025006PROPHY AIRLITE 4-HOLE50250062023-02-10
D8265025008PHOPHY AIRLITE 4-HOLE50250082023-02-10
D826LX100B2LYNX CLASSIC MOTORLX100B2H2023-02-10
D826LX10104LYNX 4:1 REDUCTION CONTRA ANGLELX1012023-02-10
D826LX11SNCL03LYNX LONG BLUE NOSECONELX11SNCL2023-02-10
D826LX11SNCS03LYNX SHORT BLUE NOSECONELX11SNCS2023-02-10
D826LX14SNCL04LYNX 4:1 REDUCTION NOSECONELX14SNCL2023-02-10
D826LXPRO54LYNX PRO 5LXPRO5-4H2023-02-10
D826LXTM52TORQUEMASTER 5 2-HOLELXTM522023-02-10
D826LXTM54TORQUEMASTER 5 4-HOLELXTM542023-02-10
D826TM204TORQUEMASTER 20 4HOLETM2042023-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640397422028Statcare sprayDent4You AGEFB2026-04-24
07640397422035Statmatic sprayDent4You AGEFB2026-04-24
J021020835001MCA-RM-BCW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J0071600436001USA1PM 1:2Bien-Air Dental SAEFB2025-10-13
J0071600052001USA1PM 1:1 EXT SPRAYBien-Air Dental SAEFB2025-10-10
J0071600692001USA1CA 20:1 L MICRO-SERIESBien-Air Dental SAEFB2025-10-10
J0071601136001USA1CA NOVA 1:1L MSBien-Air Dental SAEFB2025-10-10
J0071601138001USA1CA NOVA 1:5L MSBien-Air Dental SAEFB2025-10-10
J021300850001WG-67 AW & H Dentalwerk Bürmoos GmbHEFB2025-03-04
J021300740001TE-95 BC TurbineW & H Dentalwerk Bürmoos GmbHEFB2024-07-29
J021112330111OS30W & H Dentalwerk Bürmoos GmbHEFB2024-07-03
J00715031850011NGO motor driverBien-Air Dental SAEFB2023-09-15
J021026904001MCA-RM-RQW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021026930001MCA-ISO-CKW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021031035001MCA-ISO-MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021052046001MCA-ISO-PLW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021060371001Universal Adapter VDWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021111443001RC-43 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021112458001RC-58 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301040001AM-25 A BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301090001AM-20 E BCW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301110001AM-25 E BC AirmotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301120001AM-25 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301130001AM-20 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301240011WE-56 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301250011WE-57 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301260011HE-43 T MW Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301270011WE-56 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301280011WE-57 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301290011HE-43 T SD Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11