FDA.reportPublic FDA data

MASTER SWIVEL COUPLER

Primary DI
D826501340
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
OTC
false
Sterile
false
Single use
false

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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D7022666550StarDentalDENTALEZ, INC.EFB2026-09-18
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