FDA.reportPublic FDA data

Two Striper

Primary DI
B868CFMPSSG10080
Brand
Two Striper
Company
ABRASIVE TECHNOLOGY, INC.
Model
MANDRELS FOR LUMINESCENCE
Catalog number
CFMPSSG1008
Device description
Mandrel
Published
2021-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EHKCUP, PROPHYLAXIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHKCup, ProphylaxisDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B868CFMPSSG10081PrimaryHIBCC0
B868CFMPSSG10080Unit of UseHIBCC0

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
054028295
Device count
2
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00840456220474JMUJMU DENTAL, INCEHK2026-07-07
00840456220481JMUJMU DENTAL, INCEHK2026-07-07
00840456220498JMUJMU DENTAL, INCEHK2026-07-07
00840456220504JMUJMU DENTAL, INCEHK2026-07-07
00840456220115JMUJMU DENTAL, INCEHK2026-06-25
00840456220122JMUJMU DENTAL, INCEHK2026-06-25
00840456220139JMUJMU DENTAL, INCEHK2026-06-25
00840456220146JMUJMU DENTAL, INCEHK2026-06-25
00840456220153JMUJMU DENTAL, INCEHK2026-06-25
00840456220160JMUJMU DENTAL, INCEHK2026-06-25
00840456220177JMUJMU DENTAL, INCEHK2026-06-25
00840456220184JMUJMU DENTAL, INCEHK2026-06-25
00840456220191JMUJMU DENTAL, INCEHK2026-06-25
00840456220207JMUJMU DENTAL, INCEHK2026-06-25
00840456220214JMUJMU DENTAL, INCEHK2026-06-25
00840456220221JMUJMU DENTAL, INCEHK2026-06-25
00840456220238JMUJMU DENTAL, INCEHK2026-06-25
00840456220245JMUJMU DENTAL, INCEHK2026-06-25
00840456220252JMUJMU DENTAL, INCEHK2026-06-25
00840456220269JMUJMU DENTAL, INCEHK2026-06-25
00840456220276JMUJMU DENTAL, INCEHK2026-06-25
07897990300103PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300110PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300127PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300219PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300233PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300264PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300271PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300288PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300295PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18