FDA.report

PRAXIS

Primary DI
07897990300714
Brand
PRAXIS
Company
TDV DENTAL LTDA
Model
0002000046
Catalog number
0002000046
Device description
Praxis Refill 3/8" - 50 Fine Discs (EN)
Published
2025-02-28
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

Related Records

Product Codes

CodeName
EHJDisk, Abrasive

Product Code Classifications

CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07897990300714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07897990300714078979903007147897990300714

GMDN Terms

TermDefinition
Dental abrasive disk, single-useA dental instrument consisting of a circular flat or slightly conical sheet, which may carry or contain an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns). It is designed to be fixed at its centre to a laboratory mandrel or lathe, and/or intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
900580358
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 DIBrandModelCatalogPublished
07897990399091UNIMATRIX S000302030100030203012026-02-18
07897990399213UNIMATRIX S000302030000030203002026-02-18
07897990399220UNIMATRIX S000302030200030203022026-02-18
07897990301919METALLIC MATRIX STRIP000306000700030600072025-03-04
07897990301940METALLIC MATRIX STRIP000306001000030600102025-03-04
07897990302244ANATOMIC WEDGES000402002200040200222025-03-04
07897990302251ANATOMIC WEDGES000402002300040200232025-03-04
07897990302268ANATOMIC WEDGES000402002400040200242025-03-04
07897990302343MICROCUT MANUAL000500000700050000072025-03-04
07897990302428TRANSPARENT CROWNS000800000500080000052025-03-04
07897990302435TRANSPARENT CROWNS000800000600080000062025-03-04
07897990302442TRANSPARENT CROWNS000800000700080000072025-03-04
07897990302466TRANSPARENT CROWNS000800000900080000092025-03-04
07897990306297METALLIC MATRIX STRIP000306001800030600182025-03-04
07897990306303METALLIC MATRIX STRIP000306001900030600192025-03-04
07897990307126TRANSPARENT CROWNS000800050000080005002025-03-04
07897990307133TRANSPARENT CROWNS000800050100080005012025-03-04
07897990307140TRANSPARENT CROWNS000800050200080005022025-03-04
07897990307157TRANSPARENT CROWNS000800050300080005032025-03-04
07897990307164TRANSPARENT CROWNS000800050400080005042025-03-04

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