FDA.reportPublic FDA data

Zarc

Primary DI
06941877827809
Brand
Zarc
Company
Changzhou Sifary Medical Technology Co., Ltd.
Model
Z-Evo
Catalog number
6080279
Device description
Z-Evo is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.
Published
2026-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKXHandpiece, Direct Drive, Ac-Powered
LQYLocator, Root Apex

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1
LQYLocator, Root ApexUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201993000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201993000E-connect S Endo Motor with built-in Apex LocatorChangzhou Sifary Medical Technology Co., Ltd.2021-01-29EKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941877827809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941877827809069418778278096941877827809

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
560366787
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
06941877840372EighteethibT5035E(5X350-Elite-TR90-Wide-BK-FDA)50882182026-11-03
06941877840389EighteethibT5035E(5X350-Elite-TR90-Wide-SL-FDA)50882192026-11-03
06941877840396EighteethibT5040E(5X400-Elite-TR90-Wide-BK-FDA)50882202026-11-03
06941877840402EighteethibT5040E(5X400-Elite-TR90-Wide-SL-FDA)50882212026-11-03
06941877840419EighteethibT5045E(5X450-Elite-TR90-Wide-BK-FDA)50882222026-11-03
06941877840426EighteethibT5045E(5X450-Elite-TR90-Wide-SL-FDA)50882232026-11-03
06941877840433EighteethibT5050E(5X500-Elite-TR90-Wide-BK-FDA)50882242026-11-03
06941877840440EighteethibT5050E(5X500-Elite-TR90-Wide-SL-FDA)50882252026-11-03
06941877840457EighteethibT5035E(5X350-Elite-TR90-Narrow-BK-FDA)50882262026-11-03
06941877840464EighteethibT5035E(5X350-Elite-TR90-Narrow-SL-FDA)50882272026-11-03
06941877840471EighteethibT5040E(5X400-Elite-TR90-Narrow-BK-FDA)50882282026-11-03
06941877840488EighteethibT5040E(5X400-Elite-TR90-Narrow-SL-FDA)50882292026-11-04
06941877840495EighteethibT5045E(5X450-Elite-TR90-Narrow-BK-FDA)50882302026-11-04
06941877840501EighteethibT5045E(5X450-Elite-TR90-Narrow-SL-FDA)50882312026-11-04
06941877840518EighteethibT5050E(5X500-Elite-TR90-Narrow-BK-FDA)50882322026-11-04
06941877840525EighteethibT5050E(5X500-Elite-TR90-Narrow-SL-FDA)50882332026-11-04
06941877830519KulzerKulzer Translux Cure65800092026-10-19
06941877830557EighteethHyperLight-M70803272026-10-08
06941877830090EighteethE-FLEX REC-20351831062026-06-09
06941877830106EighteethE-FLEX REC-22051831232026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313237511ChecQPEGDENTIS CO. ,LTDEKX2026-09-29
08800313237528ChecQPEGDENTIS CO. ,LTDEKX2026-09-29
06979865810038JAS MotorDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDEKX2026-09-24
06944843624365Ultrapro TX CordlessULTRADENT PRODUCTS, INC.EKX2026-09-19
09010522003015Osstell SmartPeg Type 116Osstell ABEKX2026-08-30
09010522003022Osstell SmartPeg Type 118Osstell ABEKX2026-08-30
09010522003039Osstell SmartPeg Type 119Osstell ABEKX2026-08-30
09010522003046Osstell SmartPeg Type 120Osstell ABEKX2026-08-30
09010522003053Osstell SmartPeg Type 121Osstell ABEKX2026-08-30
09010522003060Osstell SmartPeg Type 122Osstell ABEKX2026-08-30
09010522003077Osstell SmartPeg Type 123Osstell ABEKX2026-08-30
08800313230017ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230024ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230031ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230048ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230055ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230062ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237429ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237436ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237443ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237450ChecQPEGDENTIS CO. ,LTDEKX2026-08-26