FDA.reportPublic FDA data

Two Striper

Primary DI
B868C8400051
Brand
Two Striper
Company
ABRASIVE TECHNOLOGY, INC.
Model
STAINBUSTER 4001 TEN 6-BUR PACKS
Catalog number
C840005
Device description
Abrasive Point
Published
2021-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
B868C8400051PrimaryHIBCC0
B868C8400050Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric dental burA rotary device intended to be attached to a slow speed dental handpiece that provides the rotation to enable the device to remove infected/decayed dentin without harming healthy zones of dentin. It is made of glass-bead-reinforced polymer or polyetheretherketone (PEEK) designed to deform on encountering harder, healthy dentin. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
054028295
Device count
60
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B868CFES00171Two Striper379-023SCCFES00172025-09-01
B868CFES00181Two Striper379-023FCFES00182025-09-01
B868CDCP00011Prodia Carbides2CDCP00012026-05-06
B868CDCP00021Prodia Carbides2CDCP00022026-05-06
B868CDCP00031Prodia Carbides4CDCP00032026-05-06
B868CDCP00041Prodia Carbides4CDCP00042026-05-06
B868CDCP00051Prodia Carbides6CDCP00052026-05-06
B868CDCP00061Prodia Carbides6CDCP00062026-05-06
B868CDCP00071Prodia Carbides245CDCP00072026-05-06
B868CDCP00081Prodia Carbides245CDCP00082026-05-06
B868CDCP00091Prodia Carbides330CDCP00092026-05-06
B868CDCP00101Prodia Carbides330CDCP00102026-05-06
B868CDCP00111Prodia Carbides557CDCP00112026-05-06
B868CDCP00121Prodia Carbides557CDCP00122026-05-06
B868CDCP00131Prodia Carbides331CDCP00132026-05-06
B868CDCP10011Prodia Carbides7378CDCP10012026-05-06
B868CDCP10021Prodia Carbides7379CDCP10022026-05-06
B868CDCP10031Prodia Carbides7404CDCP10032026-05-06
B868CDCP10041Prodia Carbides7406CDCP10042026-05-06
B868CDCP10051Prodia Carbides7408CDCP10052026-05-06

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