FDA.reportPublic FDA data

PWR Perio Powder Mint

Primary DI
04064896000601
Brand
PWR Perio Powder Mint
Company
PRISMAN INC.
Model
AP-PM
Device description
Prophylaxis powder based on non-cariogenic glycine (approx. 25µ). For the gentle, abrasive removal of supra- and subgingival plaque and discoloration on teeth.
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
04064896000601PackageGS12In Commercial Distribution
04064896000595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064896000601040648960006014064896000601
04064896000595040648960005954064896000595

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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17310236901089ProphyCare HApDirecta ABEJR2025-09-01
10304040192778Henry ScheinHENRY SCHEIN, INC.EJR2025-07-02
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07615208479218VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479225VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479232VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479249VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479379VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208480054VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
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