FDA.reportPublic FDA data

Eighteeth

Primary DI
06972597780648
Brand
Eighteeth
Company
Changzhou Sifary Medical Technology Co., Ltd.
Model
E-connect S
Published
2024-03-25
Public version status
Update
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
06972597780648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972597780648069725977806486972597780648

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