FDA.reportPublic FDA data

NIC/SUPERLINE

Primary DI
06944835130195
Brand
NIC/SUPERLINE
Company
Shenzhen Superline Technology Co., Ltd.
Model
Alpha Endo
Device description
Alpha Endo Handpiece is an endodontic treatment motorized handpiece. It can be used to enlarge the canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
Published
2025-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
EKXHandpiece, Direct Drive, Ac-Powered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252223000Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.2025-10-16EKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944835130195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944835130195069448351301956944835130195

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

Regulatory Flags#

DUNS number
527943851
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944835190366NIC or SUPERLINEDiabolo Amalgam Remover2025-09-18
06944835190410NIC or SUPERLINE Barrel 2025-09-18
06944835190496NIC or SUPERLINEDonut2025-09-18
06944835190571NIC or SUPERLINECylinder Flat End2025-09-18
06944835190816NIC or SUPERLINECylinder Beveled End2025-09-18
06944835190281NIC or SUPERLINEInverted Cone 2025-09-18
06944835190373NIC or SUPERLINEDiabolo Amalgam Remover2025-09-18
06944835190427NIC or SUPERLINE Barrel 2025-09-18
06944835190502NIC or SUPERLINEDonut2025-09-18
06944835190588NIC or SUPERLINECylinder Flat End2025-09-18
06944835190823NIC or SUPERLINECylinder Beveled End2025-09-18
06944835190007NIC or SUPERLINERound2025-09-17
06944835190014NIC or SUPERLINERound2025-09-17
06944835199918NIC or SUPERLINEAlpha Apex I2025-04-28
01069448351999NIC or SUPERLINEAlpha Apex I2025-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
08800313237467ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237474ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237481ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237498ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237504ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
06944843655932COLTENEGuilin Woodpecker Medical Instrument Co., Ltd.EKX2026-08-18
10817417020227AsepticoASEPTICO, INC.EKX2026-04-08
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10817417020418AsepticoASEPTICO, INC.EKX2026-04-03
10817417020425AsepticoASEPTICO, INC.EKX2026-04-03
10817417020432AsepticoASEPTICO, INC.EKX2026-04-03
10817417020449AsepticoASEPTICO, INC.EKX2026-04-03
08809260475458E-CUBESaeshin Precision Co., Ltd.EKX2026-03-31
10194665008475A-decA-DEC, INC.EKX2026-02-19
10194665008482A-decA-DEC, INC.EKX2026-02-19
10194665008499A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.EKX2026-02-19
10194665008512A-decA-DEC, INC.EKX2026-02-19