FDA.reportPublic FDA data

Strauss Diamond

Primary DI
D112POLIH330K1
Brand
Strauss Diamond
Company
Diamond Strauss Instruments Inc
Model
POLIH330K
Published
2022-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EJRAgent, Polishing, Abrasive, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D112POLIH330K1PrimaryHIBCC0

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
Dry Heat Sterilization

Regulatory Flags#

DUNS number
045784021
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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EMICESB01Ena ShinyMICERIUM SPAEJR2025-11-07
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17310236901089ProphyCare HApDirecta ABEJR2025-09-01
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07615208479218VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479225VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479232VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479249VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479379VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208480054VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
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