FDA.report

Strauss Diamond

Primary DI
D112CARBSDB61
Brand
Strauss Diamond
Company
Diamond Strauss Instruments Inc
Model
CARBSDB6
Published
2022-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EJLBur, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D112CARBSDB61PrimaryHIBCC0

GMDN Terms

TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

Method
Dry Heat Sterilization

Regulatory Flags

DUNS number
045784021
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D112KITSCCP11Strauss DiamondKITSCCP12022-10-18
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

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Primary DIBrandCompanyProduct codePublished
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00810126508294Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508300Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508317Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508324Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
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