FDA.reportPublic FDA data

"Monolith Prophy Paste MEDIUM ""BerryLime"" Cup"

Primary DI
04064896000380
Brand
"Monolith Prophy Paste MEDIUM ""BerryLime"" Cup"
Company
PRISMAN INC.
Model
M510
Published
2021-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04064896000380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064896000380040648960003804064896000380

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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
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
04064896000458Monolith Prophy Powder Genie Smile PERIO PLUSM5162021-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMICESA01Ena ShinyMICERIUM SPAEJR2025-11-07
EMICESB01Ena ShinyMICERIUM SPAEJR2025-11-07
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17310236901089ProphyCare HApDirecta ABEJR2025-09-01
10304040192778Henry ScheinHENRY SCHEIN, INC.EJR2025-07-02
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07615208479201VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
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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