s-Clean Couple Abutment

GUDID 08806169169952

Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff3.3mm / Non-Hex

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169169952
NIH Device Record Key7c333d1e-fe8c-4900-855f-a0576634300b
Commercial Distribution StatusIn Commercial Distribution
Brand Names-Clean Couple Abutment
Version Model NumberDSCA5535N4
Company DUNS688204158
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
GS108806169169952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

[08806169169952]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-05-15

On-Brand Devices [s-Clean Couple Abutment]

08806169101846Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff5.3mm / Hex
08806169101839Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff4.3mm / Non-Hex
08806169101822Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff4.3mm / Hex
08806169101815Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff3.3mm / Non-Hex
08806169101808Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff3.3mm / Hex
08806169101792Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff2.3mm / Non-Hex
08806169101785Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff2.3mm / Hex
08806169101778Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff1.8mm / Non-Hex
08806169101761Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff1.8mm / Hex
08806169101754Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff1.3mm / Non-Hex
08806169101747Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff1.3mm / Hex
08806169101730Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff5.3mm / Non-Hex
08806169101723Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff5.3mm / Hex
08806169101716Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff4.3mm / Non-Hex
08806169101709Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff4.3mm / Hex
08806169101693Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff3.3mm / Non-Hex
08806169101686Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff3.3mm / Hex
08806169101679Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff2.3mm / Non-Hex
08806169101662Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff2.3mm / Hex
08806169101655Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff1.8mm / Non-Hex
08806169101648Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff1.8mm / Hex
08806169101631Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff1.3mm / Non-Hex
08806169101624Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff1.3mm / Hex
08806169101617Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff0.8mm / Non-Hex
08806169101600Dental Implant System / s-Clean Couple Abutment D5.5mm, Cuff0.8mm / Hex
08806169101594Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff5.3mm / Non-Hex
08806169101587Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff5.3mm / Hex
08806169101570Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff4.3mm / Non-Hex
08806169101563Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff4.3mm / Hex
08806169101556Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff3.3mm / Non-Hex
08806169101549Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff3.3mm / Hex
08806169101532Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff2.3mm / Non-Hex
08806169101525Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff2.3mm / Hex
08806169101518Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff1.8mm / Non-Hex
08806169101501Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff1.8mm / Hex
08806169101495Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff1.3mm / Non-Hex
08806169101488Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff1.3mm / Hex
08806169101471Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff0.8mm / Non-Hex
08806169101464Dental Implant System / s-Clean Couple Abutment D4.5mm, Cuff0.8mm / Hex
08806169102263Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff5.3mm / Non-Hex
08806169102256Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff5.3mm / Hex
08806169102249Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff4.3mm / Non-Hex
08806169102232Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff4.3mm / Hex
08806169102225Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff3.3mm / Non-Hex
08806169102218Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff3.3mm / Hex
08806169102201Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff2.3mm / Non-Hex
08806169102195Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff2.3mm / Hex
08806169102188Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff1.8mm / Non-Hex
08806169102171Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff1.8mm / Hex
08806169102164Dental Implant System / s-Clean Couple Abutment D6.5mm, Cuff1.3mm / Non-Hex
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