s-Clean Temporary Abutment

GUDID 08806169192301

Dental Implant System / s-Clean Temporary Abutment Set (Abutment + Abutment Screw)

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use

Primary Device ID	08806169192301
NIH Device Record Key	a75da149-6f23-4c09-bafa-65a1c85e679c
Commercial Distribution Status	In Commercial Distribution
Brand Name	s-Clean Temporary Abutment
Version Model Number	DSPT55NS
Company DUNS	688204158
Company Name	DENTIS CO., LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806169192301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171027

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

[08806169192301]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-06-06
Device Publish Date	2019-05-29

On-Brand Devices [s-Clean Temporary Abutment]

08806169109941	Dental Implant System / s-Clean Temporary Abutment D6.0mm / Non-Hex
08806169102645	Dental Implant System / s-Clean Temporary Abutment D6.5mm / Non-Hex
08806169102638	Dental Implant System / s-Clean Temporary Abutment D6.5mm / Hex
08806169102621	Dental Implant System / s-Clean Temporary Abutment D5.5mm / Non-Hex
08806169102614	Dental Implant System / s-Clean Temporary Abutment D5.5mm / Hex
08806169102607	Dental Implant System / s-Clean Temporary Abutment D4.5mm / Non-Hex
08806169102591	Dental Implant System / s-Clean Temporary Abutment D4.5mm / Hex
08806169113801	Dental Implant System / s-Clean Temporary Abutment D4.0mm X L13.0mm / Hex / Titanium
08806169113795	Dental Implant System / s-Clean Temporary Abutment D4.0mm X L13.0mm / Hex / Titanium
08806169110008	Dental Implant System / s-Clean Temporary Abutment D6.5mm / Non-Hex
08806169109996	Dental Implant System / s-Clean Temporary Abutment D6.5mm / Hex
08806169109989	Dental Implant System / s-Clean Temporary Abutment D5.5mm / Non-Hex
08806169109972	Dental Implant System / s-Clean Temporary Abutment D5.5mm / Hex
08806169109965	Dental Implant System / s-Clean Temporary Abutment D4.5mm / Non-Hex
08806169109958	Dental Implant System / s-Clean Temporary Abutment D4.5mm / Hex
08806169109934	Dental Implant System / s-Clean Temporary Abutment D6.0mm / Hex
08806169109927	Dental Implant System / s-Clean Temporary Abutment D4.8mm / Non-Hex
08806169109910	Dental Implant System / s-Clean Temporary Abutment D4.8mm / Hex
08806169109903	Dental Implant System / s-Clean Temporary Abutment D6.0mm / Non-Hex
08806169109897	Dental Implant System / s-Clean Temporary Abutment D6.0mm / Hex
08806169109880	Dental Implant System / s-Clean Temporary Abutment D4.8mm / Non-Hex
08806169109873	Dental Implant System / s-Clean Temporary Abutment D4.8mm / Hex
08806169191496	Dental Implant System / s-Clean Temporary Abutment Set (Abutment + Abutment Screw) / Titanium
08806169191489	Dental Implant System / s-Clean Temporary Abutment Set (Abutment + Abutment Screw) / Titanium
08806169192325	Dental Implant System / s-Clean Temporary Abutment Set (Abutment + Abutment Screw)
08806169192318	Dental Implant System / s-Clean Temporary Abutment Set (Abutment + Abutment Screw)
08806169192301	Dental Implant System / s-Clean Temporary Abutment Set (Abutment + Abutment Screw)
08806169192295	Dental Implant System / s-Clean Temporary Abutment Set (Abutment + Abutment Screw)
08806169192288	Dental Implant System / s-Clean Temporary Abutment Set (Abutment + Abutment Screw)
08806169192271	Dental Implant System / s-Clean Temporary Abutment Set (Abutment + Abutment Screw)
08806169192264	Dental Implant System / s-Clean Temporary Abutment Set (Abutment + Abutment Screw)
08806169192257	Dental Implant System / s-Clean Temporary Abutment Set (Abutment + Abutment Screw)
08806169192240	Dental Implant System / s-Clean Temporary Abutment Set (Abutment + Abutment Screw)
08806169192233	Dental Implant System / s-Clean Temporary Abutment Set (Abutment + Abutment Screw)

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