FDA.reportPublic FDA data

Lynx Pro

Primary DI
D950131830
Brand
Lynx Pro
Company
LARES RESEARCH
Model
500 Standard Fiber-Optic
Catalog number
13183
Device description
Lynx Pro 550 Handpiece Push button Standard Head Fiber Optic
Published
2024-10-18
Public version status
New
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
D950131830PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motorized handpiece/set, pneumaticA pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes a pneumatic motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device.

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
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
J0071602490011HOSE MX2 400 GREY_102646BIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2026-08-27
07613353240011AIR-FLOWE.M.S. Electro Medical Systems S.A.EFB2026-07-21
07613353046897AIR-FLOW® PERIO handy 3.0 PERIO handpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353239992AIR-FLOW Handpiece 120°E.M.S. Electro Medical Systems S.A.EFB2026-07-14