FDA.reportPublic FDA data

Smoothdrive

Primary DI
D950135110
Brand
Smoothdrive
Company
LARES RESEARCH
Model
Motor Control System with Fluoresce HD
Catalog number
13511
Device description
Smoothdrive electric dental motor control system with Fluoresce HD motor
Published
2025-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220873000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220873000Perceptive electric dental motor and control unitLares Research2022-12-15EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D950135110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system control unit, line-poweredA mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5303451767bholderbein@laresdental.com

Regulatory Flags#

DUNS number
009127838
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
D950LC00161CybercutFG CARBIDE 4LC00162025-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
07898971838004OlsenOlsen Indústria e Comércio S/AEIA2026-04-22
J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
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