FDA.reportPublic FDA data

Pumice Preppies Plus

Primary DI
D04003410100
Brand
Pumice Preppies Plus
Company
WHIP-MIX CORPORATION
Model
03410
Catalog number
03410
Device description
A 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.
Published
2020-08-24
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
D04003410100PrimaryHIBCC0

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
006385173
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D04071079C1Surgical Guide for Carbon71079-C2021-06-07
D040711751Veriguide OS71175711752020-09-22
D040600001ARDENT600002025-11-05
D040600011ARDENT600012025-11-05
D040600071ARDENT600072025-11-05
D040600081ARDENT 600082023-10-27
D040602061ARDENT 602062023-10-27
D040600021ARDENT DISPOSABLE DENT600022023-08-18
D040600031ARDENT DISPOSABLE DENT600032023-08-18
D040603000Forceps- Paper603002023-08-18
D0406010072Articulating paper/film60100601002020-08-24
D0406010160Articulating paper/film60101601012020-08-24
D0406020075Articulating paper/film60200602002020-08-24
D0406020175Articulating paper/film60201602012020-08-24
D0406020275Articulating paper/film60202602022020-08-24
D04060002140Articulating paper/film60002600022020-08-17
D04060003140Articulating paper/film60003600032020-08-17
D04060004140Articulating paper/film60004600042020-08-17
D04060005144Articulating paper/film60005600052020-08-17
D04060006144Articulating paper/film60006600062020-08-17

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