FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919962267
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5030792U0
Device description
EP AI1 HEAD COVER 5PCS
Published
2023-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K203320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203320000Endo MotorGuilin Woodpecker Medical Instrument Co., Ltd.2021-05-10EKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919962267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919962267008879199622678879199622670887919962267

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

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535030853Brasseler USA5032379U05032379U02026-08-21
08404535030822Brasseler USA5032378U05032378U02026-07-13
00887919912125Brasseler USA5029292U05029292U02023-01-25
00887919752943Brasseler USA5025355U05025355U02026-07-27
00887919838074Brasseler USA5027336U05027336U02023-01-25
00887919711650Brasseler USA5024422U05024422U02026-06-19
00887919711681Brasseler USA5024423U05024423U02026-06-19
00887919683902Brasseler USA5023604U05023604U02026-07-13
08404535030761Brasseler USA5032375U05032375U02026-07-13
08404535030792Brasseler USA5032376U05032376U02026-07-13
08404535018981Brasseler USA5031820U05031820U02026-06-26
08404535019018Brasseler USA5031821U05031821U02026-06-26
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10817417020326AsepticoASEPTICO, INC.EKX2026-04-08
10817417020371AsepticoASEPTICO, INC.EKX2026-04-06
10817417020388AsepticoASEPTICO, INC.EKX2026-04-06
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