FDA.reportPublic FDA data

Ultrapro TX Cordless

Primary DI
00883205035462
Brand
Ultrapro TX Cordless
Company
ULTRADENT PRODUCTS, INC.
Model
5739-
Catalog number
5739-
Device description
Ultrapro Tx Cordless Prophy - Motor of Handpiece Repair Part
Published
2023-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K211531000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211531000Cordless Prophy System, Model: i-PolishGuilin Woodpecker Medical Instrument Co., Ltd.2021-12-17EKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205035462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205035462008832050354628832050354620883205035462

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motor, electricA hand-held, electrically-powered component of a dental power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883205104205Composite Wetting Resin305930592016-09-22
00883205046086Opalescence6295-US6295-US2026-08-29
00883205102652UltraEZ574357432016-09-22
06944843624365Ultrapro TX Cordless5275-5275-2026-09-19
00883205026286Ultrapro TxS8303S83032026-08-22
00883205029102OpalDam1824-U1824-U2026-08-22
00883205029119OpalDam1825-U1825-U2026-08-22
00883205029126OpalDam1826-U1826-U2026-08-22
00883205029133OpalDam324-U324-U2026-08-22
00883205029140OpalDam325-U325-U2026-08-22
00883205029157OpalDam326-U326-U2026-08-22
00883205041005Thermo Clone606560652026-08-22
00883205041883UltraCem205620562026-08-22
00883205043221ViscoStat Clear640764072026-08-22
00883205043238ViscoStat Clear640864082026-08-22
00883205043245ViscoStat Clear640964092026-08-22
00883205043252ViscoStat Clear641064102026-08-22
00883205043344Valo X5973-DU5973-DU2026-08-22
00883205031976STARbrush109310932024-12-07
00883205040398Halo Sectional Matrix System588358832026-06-26

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