Estheticone Abutment

GUDID 08806169105608

Ø4.8, L:3.8mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID08806169105608
NIH Device Record Key23520969-75f2-47d7-93d9-5a026595d9e6
Commercial Distribution Discontinuation2019-05-03
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEstheticone Abutment
Version Model NumberDEEA20
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
GS108806169105608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


[08806169105608]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2015-08-07

On-Brand Devices [Estheticone Abutment]

08806169105622Ø4.8, L:5.8mm
08806169105615Ø4.8, L:4.8mm
08806169105608Ø4.8, L:3.8mm
08806169105592Ø4.8, L:2.8mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.