s-Clean Pre-Milled Abutment (A-Type)

GUDID 08800053008938

Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA10NS)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, custom-made
Primary Device ID08800053008938
NIH Device Record Key56c2adb4-1382-4b17-80dc-ca0d5abe3097
Commercial Distribution StatusIn Commercial Distribution
Brand Names-Clean Pre-Milled Abutment (A-Type)
Version Model NumberDSCBA10NS
Company DUNS694721181
Company NameDENTIS CO. ,LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800053008938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800053008938]

Moist Heat or Steam Sterilization


[08800053008938]

Moist Heat or Steam Sterilization


[08800053008938]

Moist Heat or Steam Sterilization


[08800053008938]

Moist Heat or Steam Sterilization


[08800053008938]

Moist Heat or Steam Sterilization


[08800053008938]

Moist Heat or Steam Sterilization


[08800053008938]

Moist Heat or Steam Sterilization


[08800053008938]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-27
Device Publish Date2022-06-17

On-Brand Devices [s-Clean Pre-Milled Abutment (A-Type)]

08800053008945Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA14NS)
08800053008938Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA10NS)
08800053008921Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA14HS)
08800053008914Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA10HS)
08800053008860Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA14N)
08800053008853Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA10N)
08800053008846Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA14H)
08800053008839Dental Implant System / s-Clean Pre-Milled Abutment (A-Type) (DSCBA10H)

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