Lares Research 13124-A36

GUDID D95013124A360

High-speed Handpiece, 557 ProStyle SF Lite, Swivel, Fiber Optic, Ceramic, Morita Alpha connection

LARES RESEARCH

Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic
Primary Device IDD95013124A360
NIH Device Record Key0a9c906a-ef56-4318-bba2-5b39220a2792
Commercial Distribution StatusIn Commercial Distribution
Brand NameLares Research
Version Model Number557 ProStyle SF Lite SLC, Morita Alpha
Catalog Number13124-A36
Company DUNS009127838
Company NameLARES RESEARCH
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5303451767
EmailBHOLDERBEIN@LARESDENTAL.COM
Phone5303451767
EmailBHOLDERBEIN@LARESDENTAL.COM
Phone5303451767
EmailBHOLDERBEIN@LARESDENTAL.COM
Phone5303451767
EmailBHOLDERBEIN@LARESDENTAL.COM
Phone5303451767
EmailBHOLDERBEIN@LARESDENTAL.COM
Phone5303451767
EmailBHOLDERBEIN@LARESDENTAL.COM
Phone5303451767
EmailBHOLDERBEIN@LARESDENTAL.COM
Phone5303451767
EmailBHOLDERBEIN@LARESDENTAL.COM

Device Dimensions

Length4.5 Inch
Length4.5 Inch
Length4.5 Inch
Length4.5 Inch
Length4.5 Inch
Length4.5 Inch
Length4.5 Inch
Length4.5 Inch

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD95013124A360 [Primary]
HIBCCD95013124A360 [Primary]
HIBCCD95013124A360 [Primary]
HIBCCD95013124A360 [Primary]
HIBCCD95013124A360 [Primary]
HIBCCD95013124A360 [Primary]
HIBCCD95013124A360 [Primary]
HIBCCD95013124A360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHandpiece, Air-Powered, Dental
EFBHandpiece, Air-Powered, Dental
EFBHandpiece, Air-Powered, Dental
EFBHandpiece, Air-Powered, Dental
EFBHandpiece, Air-Powered, Dental
EFBHandpiece, Air-Powered, Dental
EFBHandpiece, Air-Powered, Dental
EFBHandpiece, Air-Powered, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D95013124A360]

Moist Heat or Steam Sterilization


[D95013124A360]

Moist Heat or Steam Sterilization


[D95013124A360]

Moist Heat or Steam Sterilization


[D95013124A360]

Moist Heat or Steam Sterilization


[D95013124A360]

Moist Heat or Steam Sterilization


[D95013124A360]

Moist Heat or Steam Sterilization


[D95013124A360]

Moist Heat or Steam Sterilization


[D95013124A360]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [Lares Research]

D9501373501High-speed Handpiece, R & S SupraSpeed+, Push button
D9501373400High-speed Handpiece, R & S SupraSpeed+ Mini, Push button
D9501368404High-speed Handpiece, Kent Dental Turbine Plus, Push button
D9501368303High-speed Handpiece, Kent Dental Turbine Plus Mini, Push button
D9501362403607High-speed Handpiece, 757 ProStyle SF Lite, 4-Hole, Ceramic
D9501362402202High-speed Handpiece, 757 ProStyle SF Lite, 4-Hole
D9501362103604High-speed Handpiece, 757 ProStyle SF Lite, 4-Hole Fiber optic, Ceramic
D950136210220High-speed Handpiece, 757 ProStyle SF Lite, 4-Hole Fiber optic
D9501334700Handpiece, ProStyle E, Straight, 1:1 ratio, Locking chuck
D95013307C360High-speed Handpiece, 757 ProStyle SF Lite, Swivel, Ceramic, Yoshida connection
D95013307A360High-speed Handpiece, 757 ProStyle SF Lite, Swivel, Ceramic, Morita Alpha connection
D9501330723607High-speed Handpiece, 757 ProStyle SF Lite, Swivel, Ceramic
D9501330722202High-speed Handpiece, 757 ProStyle SF Lite, Swivel
D95013305C360High-speed Handpiece, 757 ProStyle SF Lite, Swivel, Fiber optic, Ceramic, Yoshida connection
D95013305A360High-speed Handpiece, 757 ProStyle SF Lite, Swivel, Fiber optic, Ceramic, Morita Alpha connectio
D9501330523605High-speed Handpiece, 757 ProStyle SF Lite, Swivel, Fiber optic, Ceramic
D9501330522200High-speed Handpiece, 757 ProStyle SF Lite, Swivel, Fiber optic
D950132240Handpiece, ProStyle E Contra-Angle, 1:5 ratio, Push Button Latch, Classic
D950132230Handpiece, ProStyle E Contra-Angle, 1:5 ratio, Push Button Friction Grip, Classic
D950132220Handpiece, ProStyle E Contra-Angle, 1:1 ratio, Push Button Latch
D950132210Handpiece, ProStyle E Contra-Angle, 1:5 ratio, Push Button Friction Grip
D9501318601Motor Control, ProStyle E, reversing, with hose
D9501318500Electric Motor, ProStyle E, 1000-40000 rpm
D9501317701Electric Motor and Control, ProStyle E, 1000-40000 rpm
D9501314323605High-speed Handpiece, L5 757 ProStyle SF, Swivel, Ceramic
D95013142A360High-speed Handpiece, L5 757 ProStyle SF, Swivel, Fiber optic, Ceramic, Morita Alpha connection
D9501314223604High-speed Handpiece, L5 757 ProStyle SF, Swivel, Fiber optic, Ceramic
D9501314123603High-speed Handpiece, 757 ProStyle SF, Swivel, Ceramic
D950131412220High-speed Handpiece, 757 ProStyle SF, Swivel
D9501314023602High-speed Handpiece, 757 ProStyle SF, Swivel, Fiber optic, Ceramic
D950131402220High-speed Handpiece, 757 ProStyle SF, Swivel, Fiber optic
D9501313323604High-speed Handpiece, L5 557 ProStyle SF, Swivel, Ceramic
D95013132C360High-speed Handpiece, L5 557 ProStyle SF, Swivel, Fiber optic, Ceramic, Yoshida connection
D9501313223603High-speed Handpiece, L5 557 ProStyle SF, Swivel, Fiber optic, Ceramic
D9501313123602High-speed Handpiece, 557 ProStyle SF, Swivel, Ceramic
D950131312220High-speed Handpiece, 557 ProStyle SF, Swivel
D9501313023601High-speed Handpiece, 557 ProStyle SF, Swivel, Fiber optic, Ceramic
D950131302220High-speed Handpiece, 557 ProStyle SF, Swivel, Fiber optic
D9501312523605High-speed Handpiece, 557 ProStyle SF Lite, Swivel, Ceramic
D9501312522200High-speed Handpiece, 557 ProStyle SF Lite, Swivel
D95013124C360High-speed Handpiece, 557 ProStyle SF Lite, Swivel, Fiber Optic, Ceramic, Yoshida connection
D95013124A360High-speed Handpiece, 557 ProStyle SF Lite, Swivel, Fiber Optic, Ceramic, Morita Alpha connectio
D9501312423604High-speed Handpiece, 557 ProStyle SF Lite, Swivel, Fiber Optic, Ceramic
D950131242220High-speed Handpiece, 557 ProStyle SF Lite, Swivel, Fiber Optic
D950130040360High-speed Handpiece, 557 ProStyle SF Lite, 4 Hole, Ceramic
D950130040220High-speed Handpiece, 557 ProStyle SF Lite, 4 Hole
D950130020220High-speed Handpiece, 557 ProStyle SF Lite, 2 Hole Push button
D950130010360High-speed Handpiece, 557 ProStyle SF Lite, 4 Hole Fiber Optic, Ceramic
D950130010220High-speed Handpiece, 557 ProStyle SF Lite, 4 Hole Fiber Optic
D950114250Low-speed Handpiece: Pastel Plus, Silver, Prophy 0-5k rpm, straight, 4 hole

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.