FDA.reportPublic FDA data

Lares Research

Primary DI
D950131454360
Brand
Lares Research
Company
LARES RESEARCH
Model
757 ProStyle SF Lite NSK SLC
Catalog number
13145-436
Device description
High-speed dental handpiece, 757 ProStyle SF NSK SLC
Published
2024-03-15
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
D950131454360PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic dental scaling/debridement system handpieceA holder for a detachable tip that functions as part of a pneumatic dental scaling/debridement system, designed to use compressed air to generate a vibrating action at the tip to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. Water is also fed through the handpiece and attached tip to assist in the process. It is typically designed with a standard 2-, 3-, or 4-hole connector utilizing the same connection to existing air-driven handpiece tubing and the water spray for lavage. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
530.345.1767bholderbein@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
D7022666540StarDentalDENTALEZ, INC.EFB2026-09-18
D7022666550StarDentalDENTALEZ, INC.EFB2026-09-18
D950133802360Xtreme PowerLARES RESEARCHEFB2026-09-04
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
D950134802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134812360Xtreme PowerLARES RESEARCHEFB2026-09-04
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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