FDA.reportPublic FDA data

Polishers

Primary DI
04057176161185
Brand
Polishers
Company
DFS - DIAMON GmbH
Model
80093D
Device description
Uporal wheel
Published
2020-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
EHJDISK, ABRASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057176161185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057176161185040571761611854057176161185

GMDN Terms#

Term, Definition table
TermDefinition
Dental polishing brushA rotational device, typically composed of a metal shaft with bristles containing silicium carbide material, that is used for the quick grinding and polishing of dental composite materials and hard dental tissues to produce a high shine. It is held in a dental handpiece, which rotates the brush at high speeds [e.g., 5000 revolutions per minute (rpm)]. It is suitable for interproximal areas and occlusal surfaces. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316179456
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057176221360Jiffy brush10092022-06-01
04057176221384Jiffy brush8502022-06-01
04057176221353Jiffy brush10092022-06-01
04057176221377Jiffy brush8502022-06-01
04057176167125Polishers90006506012021-12-30
04057176167170Polishers90006506022021-12-30
04057176167118Polishers90006506012021-12-30
04057176167156Polishers90006501262021-12-30
04057176167163Polishers90006506022021-12-30
04057176167002Dr. Mike’s reverse prep bur kit2002152021-07-31
04057176165640FG diamond5340552021-02-15
04057176166647FG diamond5318932021-02-15
04057176166661FG diamond5351642021-02-15
04057176166685FG diamond5369852021-02-15
04057176166708FG diamond532573Mku2021-02-15
04057176166722FG diamond532793ku2021-02-15
04057176166746FG diamond533798MLG2021-02-15
04057176166760FG diamond5304742021-02-15
04057176166784FG diamond532865M2021-02-15
04057176165633FG diamond5340552021-02-15

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Primary DI, Brand, Company table
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00348783011982Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
00348783011999Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
00348783012019Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
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