FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919853848
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5027135RF
Device description
ENDOSYNC PLUS
Published
2023-01-19
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
K112665000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112665000TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECEJ. Morita USA, Inc.2012-05-04EKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919853848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919853848008879198538488879198538480887919853848

GMDN Terms#

Term, Definition table
TermDefinition
Dental laboratory power tool systemAn assembly of devices intended to be used in a dental laboratory to bore/cut/grind dental fixtures, appliances, and materials for their preparation or repair. It typically consists of a drilling handpiece, a compact mains electricity (AC-powered) motor, an enclosed and flexible spinning cable (e.g., a Bowden cable), and a variety of dental power tool attachments to hold the active instruments (e.g., drills, burs, grind wheels). The spinning cable provides power to the handpiece from the electric motor which is placed distant from the site of operation, providing additional protection from exposure to electrical current. The system is typically combined with various speed controllers.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082080136
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
00887919956815LARGE BONE BLADESSAW6944TSAW6944T2026-10-27
00887919956846LARGE BONE BLADESSAW6945TSAW6945T2026-10-27
00887919956877LARGE BONE BLADESSAW6946TSAW6946T2026-10-27
00887919956969LARGE BONE BLADESSAW6949TSAW6949T2026-10-27
00887919956990LARGE BONE BLADESSAW6950TSAW6950T2026-10-27
00887919957027LARGE BONE BLADESSAW6951TSAW6951T2026-10-27
00887919956907LARGE BONE BLADESSAW6947TSAW6947T2026-10-26
00887919956938LARGE BONE BLADESSAW6948TSAW6948T2026-10-26
08404535025309Brasseler USA5032037U05032037U02026-04-29
00887919673880Brasseler USA5022563U05022563U02023-01-25
00887919676218Brasseler USA5022790U05022790U02023-01-25
00887919676232Brasseler USA5022792U05022792U02023-01-25
00887919676249Brasseler USA5022793U05022793U02023-01-25
00887919810926Brasseler USA5026807U05026807U02023-01-25
08404535020779Brasseler USA5031841U05031841U02026-10-20
08404535020809Brasseler USA5031842U05031842U02026-10-20
08404535037654Brasseler USA5032402U05032402U02026-10-20
08404535037685Brasseler USA5032403U05032403U02026-10-20
08404535036985Brasseler USA5032405U05032405U02026-10-01
00887919581703DENTFLEX FIBER POST5013917L05013917L02026-09-28

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