FDA.reportPublic FDA data

Strauss Diamond

Primary DI
D112KITSCCP11
Brand
Strauss Diamond
Company
Diamond Strauss Instruments Inc
Model
KITSCCP1
Published
2022-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D112KITSCCP11PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
045784021
Device count
1
Premarket exempt
true
Kit
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
D112KITSCFPS11Strauss DiamondKITSCFPS12022-10-18
D112KITSCFPS21Strauss DiamondKITSCFPS22022-10-18
D112KITSCFPS31Strauss DiamondKITSCFPS32022-10-18
D112KITSCPS11Strauss DiamondKITSCPS12022-10-18
D112KITSCPS21Strauss DiamondKITSCPS22022-10-18
D112KITSGOST11Strauss DiamondKITSGOST12022-10-18
D112KITSGOST21Strauss DiamondKITSGOST22022-10-18
D112KITSGOSTBUNDLE1Strauss DiamondKITSGOSTBUNDLE2022-10-18
D112KITSGOSTBUNDLE21Strauss DiamondKITSGOSTBUNDLE22022-10-18
D112KITSGRKIT11Strauss DiamondKITSGRKIT12022-10-18
D112KITSGRKITPRO1Strauss DiamondKITSGRKITPRO2022-10-18
D112KITSHDPREP211Strauss DiamondKITSHDPREP212022-10-18
D112KITSHDSEAT211Strauss DiamondKITSHDSEAT212022-10-18
D112KITSISS11Strauss DiamondKITSISS12022-10-18
D112KITSLACPS11Strauss DiamondKITSLACPS12022-10-18
D112KITSMBVK1Strauss DiamondKITSMBVK2022-10-18
D112KITSMCPS11Strauss DiamondKITSMCPS12022-10-18
D112KITSMIS11Strauss DiamondKITSMIS12022-10-18
D112KITSMSPS11Strauss DiamondKITSMSPS12022-10-18
D112KITSMTLD11Strauss DiamondKITSMTLD12022-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243660995Alpen DiamondsDent4You AGDZP2026-09-04
07630243661237Alpen DiamondsDent4You AGDZP2026-09-04
07630243662470Alpen DiamondsDent4You AGDZP2026-09-04
07630243662494Alpen DiamondsDent4You AGDZP2026-09-04
07630243662517Alpen DiamondsDent4You AGDZP2026-09-04
07630243662531Alpen DiamondsDent4You AGDZP2026-09-04
07630243662555Alpen DiamondsDent4You AGDZP2026-09-04
07630243662579Alpen DiamondsDent4You AGDZP2026-09-04
07630243662593Alpen DiamondsDent4You AGDZP2026-09-04
07630243662616Alpen DiamondsDent4You AGDZP2026-09-04
07630243662630Alpen DiamondsDent4You AGDZP2026-09-04
07630243662654Alpen DiamondsDent4You AGDZP2026-09-04
07630243662678Alpen DiamondsDent4You AGDZP2026-09-04
07630243662692Alpen DiamondsDent4You AGDZP2026-09-04
07630243662715Alpen DiamondsDent4You AGDZP2026-09-04
07630243662739Alpen DiamondsDent4You AGDZP2026-09-04
07630243662753Alpen DiamondsDent4You AGDZP2026-09-04
07630243662777Alpen DiamondsDent4You AGDZP2026-09-04
07630243662791Alpen DiamondsDent4You AGDZP2026-09-04
07630243662814Alpen DiamondsDent4You AGDZP2026-09-04
07630243662838Alpen DiamondsDent4You AGDZP2026-09-04
07630243662852Alpen DiamondsDent4You AGDZP2026-09-04
07630243662876Alpen DiamondsDent4You AGDZP2026-09-04
07630243662890Alpen DiamondsDent4You AGDZP2026-09-04
07630243662913Alpen DiamondsDent4You AGDZP2026-09-04
07630243662937Alpen DiamondsDent4You AGDZP2026-09-04
07630243662951Alpen DiamondsDent4You AGDZP2026-09-04
07630243662975Alpen DiamondsDent4You AGDZP2026-09-04
07630243662999Alpen DiamondsDent4You AGDZP2026-09-04
07630243663019Alpen DiamondsDent4You AGDZP2026-09-04