FDA.reportPublic FDA data

s-Clean Solid Type PS Abutment

Primary DI
08806169139757
Brand
s-Clean Solid Type PS Abutment
Company
DENTIS CO. ,LTD
Model
DPSS5525
Device description
Dental Implant Instrument / s-Clean Solid Type PS Abutment
Published
2021-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806169139757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806169139757088061691397578806169139757

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment trialA copy of a dental implant abutment intended to be used intraorally during dental implant restorative procedures to reproduce the characteristics of an abutment (e.g., angle, diameter, transmucosal or cementable area height) to facilitate selection of an appropriate final prosthetic abutment. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694721181
Device count
1
Premarket exempt
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
08800313235715SQ AXEL Guide CountersinkDSAGCS502026-07-09
08800313235722SQ AXEL Guide CountersinkDSAGCS462026-07-09
08800313235739SQ AXEL Guide CountersinkDSAGCS422026-07-09
08800313235746SQ AXEL Guide CountersinkDSAGCS382026-07-09
08800313235753SQ AXEL Guide Step DrillDSAGSTD50162026-07-09
08800313235760SQ AXEL Guide Step DrillDSAGSTD50142026-07-09
08800313235777SQ AXEL Guide Step DrillDSAGSTD50122026-07-09
08800313235784SQ AXEL Guide Step DrillDSAGSTD50102026-07-09
08800313235791SQ AXEL Guide Step DrillDSAGSTD50082026-07-09
08800313235807SQ AXEL Guide Step DrillDSAGSTD46162026-07-09
08800313235814SQ AXEL Guide Step DrillDSAGSTD46142026-07-09
08800313235821SQ AXEL Guide Step DrillDSAGSTD46122026-07-09
08800313235838SQ AXEL Guide Step DrillDSAGSTD46102026-07-09
08800313235845SQ AXEL Guide Step DrillDSAGSTD46082026-07-09
08800313235852SQ AXEL Guide Step DrillDSAGSTD42162026-07-09
08800313235869SQ AXEL Guide Step DrillDSAGSTD42142026-07-09
08800313235876SQ AXEL Guide Step DrillDSAGSTD42122026-07-09
08800313235883SQ AXEL Guide Step DrillDSAGSTD42102026-07-09
08800313235890SQ AXEL Guide Step DrillDSAGSTD42082026-07-09
08800313235906SQ AXEL Guide Step DrillDSAGSTD38162026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748054Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748061Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748078Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748085Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748092Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748108Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748115Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290116660882Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
07290116660899Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
07290116660981Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235753SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235760SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235777SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235784SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235791SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235807SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235814SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235821SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235838SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235845SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235852SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235869SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235876SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235883SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235890SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235906SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09