FDA.reportPublic FDA data

ProphyCare

Primary DI
17310236901195
Brand
ProphyCare
Company
Directa AB
Model
Mix Single Dose
Catalog number
690119
Published
2022-12-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EJRAgent, Polishing, Abrasive, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17310236901195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1731023690119517310236901195

GMDN Terms#

Term, Definition table
TermDefinition
DentifriceA substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
353954381
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17310234131044TrollByteKimera Endo 4104/310415744131042026-09-21
17310235115869Directa Cheek Retractor Red Adult5115862022-12-07
17310235115876Directa Cheek Retractor Red Child5115872022-12-07
17310235115906Directa Cheek Retractor Ivory Adult5115902022-12-07
17310235115913Directa Cheek Retractor Ivory Child 5115912022-12-07
17310236901089ProphyCare HAp6901082025-09-01
17310231029993ProphyCare HAp6901082025-09-01
17310234160679DryDent Sublingual X-Small4160672022-12-06
17310230021967PrepSure1.0 mm2025-05-27
17310230021974PrepSure1.5 mm2025-05-27
17310230021981PrepSure2.0 mm2025-05-27
17310230924039PrepSure92403924032025-05-27
17310230004045TrollByteLynx Blue #115412450012022-12-06
17310230004052TrollByteLynx Blue #215413150022022-12-06
17310230004069TrollByteLynx Yellow #115434050012022-12-05
17310230004076TrollByteLynx Yellow #215434150022022-12-05
17310230001228TrollBagPSP #1131904032022-12-06
17310230004922TrollByteEzSoft #1155005102022-12-06
17310230004946TrollByteEzSoft #2155005202022-12-06
17310230006674TrollByteEzSoft #2 (Wave)155006202022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00353045001083QartzDHARMA RESEARCH, INC.EJR2026-10-14
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00353045001106QartzDHARMA RESEARCH, INC.EJR2026-10-14
00353045001113QartzDHARMA RESEARCH, INC.EJR2026-10-14
00353045001120QartzDHARMA RESEARCH, INC.EJR2026-10-14
00353045001137QartzDHARMA RESEARCH, INC.EJR2026-10-14
00353045001144QartzDHARMA RESEARCH, INC.EJR2026-10-14
00353045001151QartzDHARMA RESEARCH, INC.EJR2026-10-14
00353045001175QartzDHARMA RESEARCH, INC.EJR2026-10-14
00353045001182QartzDHARMA RESEARCH, INC.EJR2026-10-14
00353045001212QartzDHARMA RESEARCH, INC.EJR2026-10-14
00353045001229QartzDHARMA RESEARCH, INC.EJR2026-10-14
00353045001236QartzDHARMA RESEARCH, INC.EJR2026-10-14
00353045000550QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045000567QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045000598QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045000932QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045000949QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045001168QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045003773QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045003780QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045003797QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045000529QartzDHARMA RESEARCH, INC.EJR2026-10-12
00353045000536QartzDHARMA RESEARCH, INC.EJR2026-10-12
00353045000543QartzDHARMA RESEARCH, INC.EJR2026-10-12
00353045000581QartzDHARMA RESEARCH, INC.EJR2026-10-12
00353045000604QartzDHARMA RESEARCH, INC.EJR2026-10-12
00353045000611QartzDHARMA RESEARCH, INC.EJR2026-10-12
00353045000512QartzDHARMA RESEARCH, INC.EJR2026-10-09
07613353171582AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.EJR2026-07-13