s-Clean SQ-SL Mini Cover Screw

GUDID 08800053023733

Dental Implant System / s-Clean SQ-SL Mini Cover Screw (DSCSMM)

DENTIS CO. ,LTD

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08800053023733
NIH Device Record Keyb31f4915-ed75-4463-8a90-8f5192019fb6
Commercial Distribution StatusIn Commercial Distribution
Brand Names-Clean SQ-SL Mini Cover Screw
Version Model NumberDSCSMM
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800053023733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

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

Devices Manufactured by DENTIS CO. ,LTD

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08800266940971 - s-Clean MU Digital Lab2024-08-28 s-Clean MU Digital Lab (DSMUDLS)
08800266940988 - i-Clean Digital Lab Analog2024-08-28 i-Clean Digital Lab Analog (DIDLARS)
08800266940995 - i-Clean Digital Lab Analog2024-08-28 i-Clean Digital Lab Analog (DIDLAWS)
08800266941022 - s-Clean ScanBody2024-08-28 s-Clean ScanBody (DSSBRLFS)
08800266941039 - s-Clean ScanBody2024-08-28 s-Clean ScanBody (DSSBMLFS)
08800266941046 - s-Clean ScanBody2024-08-28 s-Clean ScanBody (DSSBNLFS)

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