FDA.reportPublic FDA data

POLISHING WHEELS

Primary DI
D772ATI19839E0
Brand
POLISHING WHEELS
Company
AMERICAN TOOTH INDUSTRIES
Model
09-19839 E
Device description
"12 PORCLIN POLISHING WHEELS 7/8""X1/8"""
Published
2023-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D772ATI19839E0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive point, reusableA rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
161532999
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D722ATI199925560CARBIDE BURRS016-19992-5562023-11-17
D772ATI1999220CARBIDE BURRS016-19992-22023-11-17
D772ATI1999230CARBIDE BURRS016-19992-32023-11-17
D772ATI199923350CARBIDE BURRS016-19992-33-52023-11-17
D772ATI19992340CARBIDE BURRS016-19992-342023-11-17
D772ATI19992350CARBIDE BURRS016-19992-352023-11-17
D772ATI19992360CARBIDE BURRS016-19992-362023-11-17
D772ATI19992370CARBIDE BURRS016-19992-372023-11-17
D772ATI19992380CARBIDE BURRS016-19992-382023-11-17
D772ATI19992390CARBIDE BURRS016-19992-392023-11-17
D772ATI1999240CARBIDE BURRS016-19992-42023-11-17
D772ATI1999250CARBIDE BURRS016-19992-52023-11-17
D772ATI199925570CARBIDE BURRS016-19992-5572023-11-17
D772ATI199925580CARBIDE BURRS016-19992-5582023-11-17
D772ATI199925590CARBIDE BURRS016-19992-5592023-11-17
D772ATI19992560CARBIDE BURRS016-19992-562023-11-17
D772ATI199925600CARBIDE BURRS016-19992-5602023-11-17
D772ATI19992570CARBIDE BURRS016-19992-572023-11-17
D772ATI19992580CARBIDE BURRS016-19992-582023-11-17
D772ATI19992590CARBIDE BURRS016-19992-592023-11-17

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