FDA.reportPublic FDA data

Polishers

Primary DI
04057176159052
Brand
Polishers
Company
DFS - DIAMON GmbH
Model
800118
Device description
Prophylaxis pol. set cup 20pcs
Published
2020-11-30
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
EHLPOINT, ABRASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057176159052PrimaryGS10
04057176159045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057176159052040571761590524057176159052
04057176159045040571761590454057176159045

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
20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535030426Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030433Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030464Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030488Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030518Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030549Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030570Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030600Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030631Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030662Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
00887919752943Brasseler USAPeter Brasseler Holdings, LLCEHL2026-07-27
04548162350558GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350565GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350572GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350589GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350596GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350602GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350619GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350626GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350633GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350640GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350657GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350664GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
00887919711650Brasseler USAPeter Brasseler Holdings, LLCEHL2026-06-19
00887919711681Brasseler USAPeter Brasseler Holdings, LLCEHL2026-06-19
07897990301155PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301209PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301216PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399756PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399763PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18