FDA.reportPublic FDA data

Strauss Diamond

Primary DI
D112POLIDTDCP10F1
Brand
Strauss Diamond
Company
Diamond Strauss Instruments Inc
Model
POLIDTDCP10F
Published
2022-10-17
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

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
D112POLIDTDCP10F1PrimaryHIBCC0

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
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 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
00810184450009RodinPac-Dent, Inc.EJR2026-03-23
00810184450016RodinPac-Dent, Inc.EJR2026-03-23
00810184450023RodinPac-Dent, Inc.EJR2026-03-23
E241BW9100Cavex Prophy Paste RegularCavex Holland B.V.EJR2026-03-11
E241BW9110Cavex Prophy Paste FineCavex Holland B.V.EJR2026-03-11
00883205042835OpalustreULTRADENT PRODUCTS, INC.EJR2026-03-10
10190707191174Ortho Technology®Ortho Organizers, Inc.EJR2025-10-23
17310231029993ProphyCare HApDirecta ABEJR2025-09-01
00348783012989Enamel Pro® Prophy PastePREMIER DENTAL PRODUCTS COMPANYEJR2025-07-16
00304040192771Henry ScheinHENRY SCHEIN, INC.EJR2025-07-02
06971560453466REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453473REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453480REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453497REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453503REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
D0337884100Kolorz Prophylaxis PasteDMG AMERICA, LLCEJR2025-06-04
D0337884110Kolorz Prophylaxis PasteDMG AMERICA, LLCEJR2025-06-04
D950116471PastelLARES RESEARCHEJR2025-05-02
D950116481PastelLARES RESEARCHEJR2025-05-02
00359883003081Contours™ Coarse Anatomy Trimmers Shape 05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003098Contours™ Coarse Anatomy Trimmers Shape 06DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003104Contours™ Coarse Anatomy Trimmers Shape 08DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003111Contours™ Course Anatomy Trimers Starter KitDEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003500D-Fine™ Diamond Polishers for Hybrid Composites Pre-Polisher Refill #05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003517D-Fine™ Diamond Polishers for Hybrid Composites Pre-Polisher Refill #06DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003524D-Fine™ Diamond Polishers for Hybrid Composites Diamond Polisher Refill #05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003609D-Fine Double Diamond™ Primary Polisher Refill #04DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003616D-Fine Double Diamond™ Primary Polisher Refill #05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003623D-Fine Double Diamond™ Primary Polisher Refill #06DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003630D-Fine Double Diamond™ Primary Polisher Refill #08DEN-MAT HOLDINGS, LLCEJR2025-03-12