FDA.reportPublic FDA data

PROPHY BRUSHES

Primary DI
07897990399992
Brand
PROPHY BRUSHES
Company
TDV DENTAL LTDA
Model
5013001001
Catalog number
5013001001
Device description
Prophy Brush Semi-rigid Cup Blue CA – 1 unit
Published
2026-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EHKCup, Prophylaxis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHKCup, ProphylaxisDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07897990399992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07897990399992078979903999927897990399992

GMDN Terms#

Term, Definition table
TermDefinition
Dental-professional prophylaxis brush, single-useA non-sterile rotary dental instrument with natural or synthetic bristle brushes intended to be used by a dental hygienist and/or dentist to clean and polish teeth. It is designed to be attached to a powered dental handpiece which provides the necessary rotation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
900580358
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07897990300103PROPHY BRUSHES501300100250130010022026-05-18
07897990300110PROPHY BRUSHES501300100350130010032026-05-18
07897990300127PROPHY BRUSHES501300100450130010042026-05-18
07897990300219PROPHY BRUSHES501300100550130010052026-05-18
07897990300233PROPHY BRUSHES501300100650130010062026-05-18
07897990300264PROPHY BRUSHES501300100750130010072026-05-18
07897990300271PROPHY BRUSHES501300100850130010082026-05-18
07897990300288PROPHY BRUSHES501300100950130010092026-05-18
07897990300295PROPHY BRUSHES501300101050130010102026-05-18
07897990300325PROPHY BRUSHES501300101150130010112026-05-18
07897990300332PROPHY BRUSHES501300101250130010122026-05-18
07897990301070PROPHY BRUSHES501300101350130010132026-05-18
07897990301087PROPHY BRUSHES501300101450130010142026-05-18
07897990301094PROPHY BRUSHES501300101550130010152026-05-18
07897990301100PROPHY BRUSHES501300101650130010162026-05-18
07897990301117PROPHY BRUSHES501300101750130010172026-05-18
07897990301124PROPHY BRUSHES501300101850130010182026-05-18
07897990301131PROPHY BRUSHES501300101950130010192026-05-18
07897990301148PROPHY BRUSHES501300102050130010202026-05-18
07897990301155PRAXIS POLISHERS501202101250120210122026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454002582COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454002599COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454002605COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454002612COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454002629COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454002636COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454002643COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454002650COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-23
06954454015681COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-22
06954454015698COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-22
06954454015704COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-22
06954454015711COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-22
06954454015728COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-22
06954454015735COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-22
06954454015742COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-22
06954454015759COTISENHuanghua Promisee Dental Co., Ltd.EHK2026-10-22
00883205026286Ultrapro TxULTRADENT PRODUCTS, INC.EHK2026-08-22
00840456220474JMUJMU DENTAL, INCEHK2026-07-07
00840456220481JMUJMU DENTAL, INCEHK2026-07-07
00840456220498JMUJMU DENTAL, INCEHK2026-07-07
00840456220504JMUJMU DENTAL, INCEHK2026-07-07
00840456220115JMUJMU DENTAL, INCEHK2026-06-25
00840456220122JMUJMU DENTAL, INCEHK2026-06-25
00840456220139JMUJMU DENTAL, INCEHK2026-06-25
00840456220146JMUJMU DENTAL, INCEHK2026-06-25
00840456220153JMUJMU DENTAL, INCEHK2026-06-25
00840456220160JMUJMU DENTAL, INCEHK2026-06-25
00840456220177JMUJMU DENTAL, INCEHK2026-06-25
00840456220184JMUJMU DENTAL, INCEHK2026-06-25
00840456220191JMUJMU DENTAL, INCEHK2026-06-25