FDA.reportPublic FDA data

LYNX LONG BLUE NOSECONE

Primary DI
D826LX11SNCL030
Brand
LYNX LONG BLUE NOSECONE
Company
MTI Precision Products, LLC
Model
LX11SNCL
Device description
LYNX LONG BLUE NOSECONE IS A STRAIGHT LOWSPEED DENTAL HANDPIECE ATTACHMENT THAT HOLDS BURS, DISCS AND MANDRELS WHICH WORKS TOGETHER WITH AN E-TYPE MOTOR AS A 1:1 TRANSMISSION FROM THE MOTOR TO THE BIT. IT IS USED FOR THE POLISHING OF TEETH AND REMOVAL OF CARRIES IN A DENTAL SETTING. THIS NOSECONE IS COMPATIBLE WITH ALL E-TYPE MOTORS
Published
2023-02-10
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
EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940261000LYNX LOW-SPEED HANDPIECEMti Precision Products1994-12-29EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D826LX11SNCL030Direct MarkingHIBCC0
D826LX11SNCL03PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool handpiece motorless componentA component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. 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
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
10304040196974Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
10304040196981Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
10686864060946MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864060953MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864061141MEDICOM DENTICAREAMD Medicom IncEGS2025-03-18
10686864060915MEDICOM DENTICARE SWIVEL DPA, SOFT CUPAMD Medicom IncEGS2024-09-27
10686864060922MEDICOM DENTICARE SWIVEL DPA, FIRM CUPAMD Medicom IncEGS2024-09-27
10686864060939MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSHAMD Medicom IncEGS2024-09-27
00302730002911YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002928YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002935YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002942YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002959YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002997Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003000Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003017Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003024Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003031Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003055Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003062Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003079Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003086Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003093Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003109Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003116Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29