FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919665946
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5021761U0
Device description
E288001 HYGIENE PRO MOTOR 1P
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EKXHandpiece, direct drive, ac-powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919665946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919665946008879196659468879196659460887919665946

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
082080136
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535019247Brasseler USA5031780U05031780U02026-03-24
08404535024906Brasseler USA5032029U05032029U02026-03-23
08404535024937Brasseler USA5032030U05032030U02026-03-23
08404535024968Brasseler USA5032031U05032031U02026-03-23
08404535025156LARGE BONE BLADESBR1-12100-50BR1-12100-502026-03-23
08404535024579Brasseler USAFL17CHP5032016U02026-03-17
08404535024609Brasseler USAFL17MHP5032017U02026-03-17
08404535024630Brasseler USAFL17FHP5032018U02026-03-17
08404535024661Brasseler USAFL17UF5032019U02026-03-17
08404535021769BrioPrep Sterile Diamonds5031856U05031856U02025-11-21
08404535021790BrioPrep Sterile Diamonds5031857U05031857U02025-11-21
08404535021820BrioPrep Sterile Diamonds5031858U05031858U02025-11-21
08404535021851BrioPrep Sterile Diamonds5031859U05031859U02025-11-21
08404535021882BrioPrep Sterile Diamonds5031860U05031860U02025-11-21
08404535021912BrioPrep Sterile Diamonds5031861U05031861U02025-11-21
08404535021943BrioPrep Sterile Diamonds5031862U05031862U02025-11-21
08404535021974BrioPrep Sterile Diamonds5031863U05031863U02025-11-21
08404535022001BrioPrep Sterile Diamonds5031864U05031864U02025-11-21
08404535022124BrioPrep Sterile Diamonds5031880U05031880U02025-11-21
08404535022155BrioPrep Sterile Diamonds5031881U05031881U02025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313230000ChecQPEGDENTIS CO. ,LTDEKX2026-03-03
10194665008444A-decA-DEC, INC.EKX2026-02-19
E27668665320Midwest IMPLANT 20:1SIRONA Dental Systems GmbHEKX2026-02-19
09010522002506SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002520SmartPeg Type 137Osstell ABEKX2026-02-09
06941877827809ZarcChangzhou Sifary Medical Technology Co., Ltd.EKX2026-01-05
06944835130195NIC/SUPERLINEShenzhen Superline Technology Co., Ltd.EKX2025-12-22
10817417020395AsepticoASEPTICO, INC.EKX2025-12-16
10817417020401AsepticoASEPTICO, INC.EKX2025-12-16
08056814270117EnDrive ADVANCED TECHNOLOGY RESEARCH A.T.R. SRLEKX2025-11-26
09010522002650Osstell Beacon InstrumentOsstell ABEKX2025-09-26
09010522002667MEGA ISQ II InstrumentOsstell ABEKX2025-09-26
00860011518327InnerView® System Smart Tips Perimetrics, Inc.EKX2025-07-31
08809455602683elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08809455602720elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08809455602744elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08800053084123ChecQDENTIS CO. ,LTDEKX2025-03-31
08800053092494ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092500ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092517ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092524ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092531ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092548ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092555ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092562ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092579ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092586ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092593ChecQPEG DriverDENTIS CO. ,LTDEKX2025-03-31
08800266943897ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
09010522002551Osstell SmartPeg Type 112Osstell ABEKX2025-03-27