FDA.reportPublic FDA data

Plasdent

Primary DI
D832PDS3M12701
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
PDS-3M1270
Catalog number
PDS-3M1270
Device description
"M-type Polish Discs Kit, 1/2"", 2 Mandrels, 40 Discs "
Published
2025-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D832PDS3M12701PrimaryHIBCC0
D832PDS3M12700Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive disk, single-useA dental instrument consisting of a circular flat or slightly conical sheet, which may carry or contain an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns). It is designed to be fixed at its centre to a laboratory mandrel or lathe, and/or intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a single-use device.

Regulatory Flags#

DUNS number
190377184
Device count
42
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D832CFT11PlasdentCFT-1CFT-12026-10-13
D832FT11PlasdentFT-1FT-12026-10-13
D832SAP21PlasdentSAP-2SAP-22026-10-13
D832SAP31PlasdentSAP-3SAP-32026-10-13
D832SAPR21PlasdentSAP-R2SAP-R22026-10-13
D832SAPR31PlasdentSAP-R3SAP-R32026-10-13
D832CT10L1PlasdentCT10-LCT10-L2026-10-12
D832CT10M1PlasdentCT10-MCT10-M2026-10-12
D832CT10S1PlasdentCT10-SCT10-S2026-10-12
D832CT10XL1PlasdentCT10-XLCT10-XL2026-10-12
D832CT2L1PlasdentCT2-LCT2-L2026-10-12
D832CT2M1PlasdentCT2-MCT2-M2026-10-12
D832CT2S1PlasdentCT2-SCT2-S2026-10-12
D832CT2XL1PlasdentCT2-XLCT2-XL2026-10-12
D832CT2XXL1PlasdentCT2-XXLCT2-XXL2026-10-12
D832CT6L1PlasdentCT6-LCT6-L2026-10-12
D832CT6M1PlasdentCT6-MCT6-M2026-10-12
D832CT6S1PlasdentCT6-SCT6-S2026-10-12
D832CT6XL1PlasdentCT6-XLCT6-XL2026-10-12
D832JK10L1PlasdentJK10-LJK10-L2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719965090013INTRAORAL CAMERACHUAN FU MEDICAL INSTRUMENT CO., LTD.NRD2026-10-22
06954454006757COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006764COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006771COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006788COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006795COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006801COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006818COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006825COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006832COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454013991COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014004COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014011COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014028COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014035COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
D832SPD05081PlasdentPLASDENT CORPORATIONNRD2026-07-20
00840456223246JMUJMU DENTAL, INCNRD2026-07-08
00840456223253JMUJMU DENTAL, INCNRD2026-07-08
00840456223260JMUJMU DENTAL, INCNRD2026-07-08
00840456223277JMUJMU DENTAL, INCNRD2026-07-08
00840456223284JMUJMU DENTAL, INCNRD2026-07-08
00840456223291JMUJMU DENTAL, INCNRD2026-07-08
00840456223314JMUJMU DENTAL, INCNRD2026-07-08
D832MTXA15021PlasdentPLASDENT CORPORATIONNRD2026-06-04
D832MTXA15031PlasdentPLASDENT CORPORATIONNRD2026-06-04
D130BVA6X0BaseVacR. E. Morrison Equipment IncNRD2026-01-12
10371347017875Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
10371347017882Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
10371347017899Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017905Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21