FDA.reportPublic FDA data

Spectra Fresh Strawberry

Primary DI
D967500080
Brand
Spectra Fresh Strawberry
Company
PREVEST DENPRO LIMITED
Model
Intro Pack 75g jar
Catalog number
50008
Published
2023-01-03
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
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
D967500080PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
859546940
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D967410010Rotoflex Gold files triangular cross section 21mm pack of six410012026-04-29
D967410020Rotoflex Gold files triangular cross section 25mm pack of six410022026-04-29
D967410030Rotoflex Gold files triangular cross section 31mm pack of six410032026-04-29
D967410040Rotoflex Gold files triangular cross section 17/0421mm pack of six410042026-04-29
D967410050Rotoflex Gold files triangular cross section 17/0425mm pack of six410052026-04-29
D967410060Rotoflex Gold files triangular cross section 20/0421mm pack of six410062026-04-29
D967410070Rotoflex Gold files triangular cross section 20/0425mm pack of six410072026-04-29
D967410080Rotoflex Gold files triangular cross section 25/0421mm pack of six410082026-04-29
D967410090Rotoflex Gold files triangular cross section 25/0425mm pack of six410092026-04-29
D967410100Rotoflex Gold files triangular cross section 30/0421mm pack of six410102026-04-29
D967410110Rotoflex Gold files triangular cross section 30/0425mm pack of six410112026-04-29
D967410120Rotoflex Gold files triangular cross section 35/0421mm pack of six410122026-04-29
D967410130Rotoflex Gold files triangular cross section 35/0425mm pack of six410132026-04-29
D967410140Rotoflex Gold files triangular cross section 40/0421mm pack of six410142026-04-29
D967410150Rotoflex Gold files triangular cross section 40/0425mm pack of six410152026-04-29
D967410160Rotoflex Gold files triangular cross section 20/0621mm pack of six410162026-04-29
D967410170Rotoflex Gold files triangular cross section 20/0625mm pack of six410172026-04-29
D967410180Rotoflex Gold files triangular cross section 25/0621mm pack of six410182026-04-29
D967410190Rotoflex Gold files triangular cross section 25/0625mm pack of six410192026-04-29
D967410200Rotoflex Gold files triangular cross section 30/0621mm pack of six410202026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07615208479379VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
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