FDA.reportPublic FDA data

PWR Classic Powder Mint

Primary DI
04064896000564
Brand
PWR Classic Powder Mint
Company
PRISMAN INC.
Model
AP-CM
Device description
Sodium bicarbonate prophylaxis powder (40µ) for the supragingival removal of intractable plaque and discolorations on enamel.
Published
2024-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
04064896000564PackageGS14In Commercial Distribution
04064896000557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064896000564040648960005644064896000564
04064896000557040648960005574064896000557

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive powderA dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices. It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, the cleaning of orthodontic appliances (bands and brackets), the removal of adhesive residue, and the cleaning of implants prior to loading. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117569946
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04064896000557PWR Classic Powder MintAP-CM2024-10-24
04064896000595PWR Perio Powder MintAP-PM2024-10-24
04064896000618PWR Perio Powder NeutralAP-PN2024-10-24
04064896000571PWR Classic Powder NeutralAP-CN2024-10-24
04064896000014Air SupraUS-FRESH2024-07-28
04064896000038Air SupremeUS-PLUS2024-07-28
04064896000106"Monolith Prophy Paste Xtra COARSE ""Spearmint"" Tube"M5052021-10-10
04064896000113"Monolith Prophy Paste MEDIUM ""Spearmint"" Cup"M5042021-10-10
04064896000120"Monolith Prophy Paste SENSO ""BerryLime"" Tube"M5072021-10-10
04064896000137"Monolith Prophy Paste Xtra COARSE ""Spearmint"" Cup"M5062021-10-10
04064896000151"Monolith Prophy Paste SENSO ""Spearmint"" Tube"M5012021-10-10
04064896000168"Monolith Prophy Paste MEDIUM ""Spearmint"" Tube"M5032021-10-10
04064896000175"Monolith Prophy Paste SENSO ""Spearmint"" Cup"M5022021-10-10
04064896000366"Monolith Prophy Paste SENSO ""BerryLime"" Cup"M5082021-10-10
04064896000373"Monolith Prophy Paste MEDIUM ""BerryLime"" Tube"M5092021-10-10
04064896000380"Monolith Prophy Paste MEDIUM ""BerryLime"" Cup"M5102021-10-10
04064896000397"Monolith Prophy Paste Xtra COARSE ""BerryLime"" Tube"M5112021-10-10
04064896000403"Monolith Prophy Paste Xtra COARSE ""BerryLime"" Cup"M5122021-10-10
04064896000410Monolith Prophy Paste ZIRCOM5132021-10-10
04064896000441"Monolith Prophy Powder Genie Smile TOP ""Spearmint"""M5142021-10-10

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