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

GUDID 08800053008884

Dental Implant System / s-Clean Pre-Milled Abutment (M-Type) (DSCBM14H)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, custom-made
Primary Device ID08800053008884
NIH Device Record Key5f8df826-6089-4e79-b675-fe5f5f527f0a
Commercial Distribution StatusIn Commercial Distribution
Brand Names-Clean Pre-Milled Abutment (M-Type)
Version Model NumberDSCBM14H
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
GS108800053008884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800053008884]

Moist Heat or Steam Sterilization


[08800053008884]

Moist Heat or Steam Sterilization


[08800053008884]

Moist Heat or Steam Sterilization


[08800053008884]

Moist Heat or Steam Sterilization


[08800053008884]

Moist Heat or Steam Sterilization


[08800053008884]

Moist Heat or Steam Sterilization


[08800053008884]

Moist Heat or Steam Sterilization


[08800053008884]

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 (M-Type)]

08800053008983Dental Implant System / s-Clean Pre-Milled Abutment (M-Type) (DSCBM14NS)
08800053008976Dental Implant System / s-Clean Pre-Milled Abutment (M-Type) (DSCBM10NS)
08800053008969Dental Implant System / s-Clean Pre-Milled Abutment (M-Type) (DSCBM14HS)
08800053008952Dental Implant System / s-Clean Pre-Milled Abutment (M-Type) (DSCBM10HS)
08800053008907Dental Implant System / s-Clean Pre-Milled Abutment (M-Type) (DSCBM14N)
08800053008891Dental Implant System / s-Clean Pre-Milled Abutment (M-Type) (DSCBM10N)
08800053008884Dental Implant System / s-Clean Pre-Milled Abutment (M-Type) (DSCBM14H)
08800053008877Dental Implant System / s-Clean Pre-Milled Abutment (M-Type) (DSCBM10H)

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