FDA.reportPublic FDA data

Lares Research

Primary DI
D950135020
Brand
Lares Research
Company
LARES RESEARCH
Model
Smoothdrive 1:5 Contra angle
Catalog number
13502
Device description
Motor driven dental contra angle handpiece with 1:5 gear ratio.
Published
2023-06-07
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
EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220874000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220874000Smooth Drive contra angle and straight handpiecesLares Research2022-11-07EGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D950135020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motorized handpiece/set, electricAn electrically-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 an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; 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
D950135110SmoothdriveMotor Control System with Fluoresce HD135112025-09-01
D950135030Smoothdrive1:1 Contra Angle135032025-08-25
D950116461PastelProphy angle116462025-05-02
D950116471PastelProphy paste116472025-05-02
D950116481PastelProphy paste116482025-05-02
D950LC00011CybercutFG Carbide 1/2LC00012025-05-02
D950LC00021CybercutFG CARBIDE 1/4LC00022025-05-02
D950LC00031CybercutFG CARBIDE 1557LC00032025-05-02
D950LC00041CybercutFG CARBIDE 1558LC00042025-05-02
D950LC00051CybercutFG CARBIDE 169LC00052025-05-02
D950LC00061CybercutFG CARBIDE 169LC00062025-05-02
D950LC00071CybercutFG CARBIDE 2LC00072025-05-02
D950LC00081CybercutFG CARBIDE 245LC00082025-05-02
D950LC00091CybercutFG CARBIDE 245LC00092025-05-02
D950LC00101CybercutFG CARBIDE 33 1/2LC00102025-05-02
D950LC00111CybercutFG CARBIDE 330LC00112025-05-02
D950LC00121CybercutFG CARBIDE 330 LONGLC00122025-05-02
D950LC00131CybercutFG CARBIDE 330 SHORT SHANKLC00132025-05-02
D950LC00141CybercutFG CARBIDE 35LC00142025-05-02
D950LC00151CybercutFG CARBIDE 37LC00152025-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
10304040196974Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
10304040196981Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
10686864060946MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864060953MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864061141MEDICOM DENTICAREAMD Medicom IncEGS2025-03-18
10686864060915MEDICOM DENTICARE SWIVEL DPA, SOFT CUPAMD Medicom IncEGS2024-09-27
10686864060922MEDICOM DENTICARE SWIVEL DPA, FIRM CUPAMD Medicom IncEGS2024-09-27
10686864060939MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSHAMD Medicom IncEGS2024-09-27
00302730002911YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002928YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002935YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002942YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002959YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002997Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003000Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003017Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003024Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003031Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003055Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003062Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003079Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003086Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003093Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003109Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003116Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29