FDA.reportPublic FDA data

Lares Research

Primary DI
D95013307C360
Brand
Lares Research
Company
LARES RESEARCH
Model
757 ProStyle SF Lite SC Yoshida
Catalog number
13307-C36
Device description
High-speed Handpiece, 757 ProStyle SF Lite, Swivel, Ceramic, Yoshida connection
Published
2020-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K141221000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141221000LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PRLares Research, Inc.2014-10-28EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D95013307C360PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, pneumaticA hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4.5Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5303451767BHOLDERBEIN@LARESDENTAL.COM

Regulatory Flags#

DUNS number
009127838
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D950133802360Xtreme PowerXP Mini head signature grip, optic13380-2362026-09-04
D950133812360Xtreme PowerXP Mini head signature grip13381-2362026-09-04
D950133822360Xtreme PowerXP3 Mini head signature grip, optic13382-2362026-09-04
D950133832360Xtreme PowerXP3 Mini head signature grip13383-2362026-09-04
D950133842360Xtreme PowerXP5 Mini head signature grip, optic13384-2362026-09-04
D950133852360Xtreme PowerXP5 Mini head signature grip13385-2362026-09-04
D950133902360Xtreme PowerXP Standard head signature grip, optic13390-2362026-09-04
D950133912360Xtreme PowerXP Standard head signature grip13391-2362026-09-04
D950133922360Xtreme PowerXP3 Standard head signature grip, optic13392-2362026-09-04
D950133932360Xtreme PowerXP3 Standard head signature grip13393-2362026-09-04
D950133942360Xtreme PowerXP5 Standard head signature grip, optic13394-2362026-09-04
D950133952360Xtreme PowerXP5 Standard head signature grip13395-2362026-09-04
D950134802360Xtreme PowerXP Mini head smooth grip, optic13480-2362026-09-04
D950134812360Xtreme PowerXP Mini head smooth grip13481-2362026-09-04
D950134822360Xtreme PowerXP3 Mini head smooth grip, optic13482-2362026-09-04
D950134832360Xtreme PowerXP3 Mini head smooth grip13483-2362026-09-04
D950134842360Xtreme PowerXP5 Mini head smooth grip, optic13484-2362026-09-04
D950134852360Xtreme PowerXP5 Mini head smooth grip13485-2362026-09-04
D950134902360Xtreme PowerXP Standard head smooth grip, optic13490-2362026-09-04
D950134912360Xtreme PowerXP Standard head smooth grip13491-2362026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D950133812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133952360Xtreme PowerLARES RESEARCHEFB2026-09-04
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D950134822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134952360Xtreme PowerLARES RESEARCHEFB2026-09-04
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