LYNX PRO 5

GUDID D826LXPRO540

PRO 5 IS A 4-HOLE 5000 RPM DENTAL MOTOR THAT ACCEPTS BURS, MANDRILS, DISCS, AND OTHER DRILL BITS TO PERFORM DRILLING AND POLISHING OF TEETH IN A DENTAL SETTING.

MTI Precision Products, LLC

Dental surgical power tool motor, pneumatic
Primary Device IDD826LXPRO540
NIH Device Record Keyc8e3e864-e2cd-49c7-b170-9454e8caba8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLYNX PRO 5
Version Model NumberLXPRO5-4H
Company DUNS081600128
Company NameMTI Precision Products, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD826LXPRO54 [Primary]
HIBCCD826LXPRO540 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHandpiece, Air-Powered, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


[D826LXPRO540]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-20
Device Publish Date2023-02-10

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D82650163040 - MASTER PRO 52023-02-20 MASTER PRO 5 A QUICK DISCONNECT 5000 RPM DENTAL MOTOR WITH PREMIUM LUBE FREE BEARINGS THAT ACCEPTS BURS, MANDRILS, DISCS, AND O

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