FDA.reportPublic FDA data

MASTER SWIVEL COUPLER

Primary DI
D82650134
Brand
MASTER SWIVEL COUPLER
Company
MTI Precision Products, LLC
Model
50134
Device description
Master Swivel Coupler is a coupler that attaches to an operatory and a handpiece allowing the pneumatic air motor to connect to the air supply and swivel freely in the users hand without having to worry about the chord tangling up.
Published
2023-02-09
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
K073652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073652000ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLENakamura Magnifier Co., Ltd.2008-03-20EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D826501340Direct MarkingHIBCC0
D82650134PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic dental handpiece couplerA short connecting device intended to couple a pneumatic dental handpiece (e.g., a dental high-speed drill handpiece, dental restorative material sonic handpiece) and the hose that connects to the dental delivery system or a control unit, to provide the operator full rotational freedom of movement of the handpiece. This device contains a swivel mechanism that allows the freedom of movement. 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
D826TM202TORQUEMASTER 20 2-HOLETM2022023-02-10

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