WN Plastic coping for WN Solid abutments, crown

GUDID 06947600302537

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600302537
NIH Device Record Key63a7709b-bb1e-402f-bdd1-574dc667610c
Commercial Distribution StatusIn Commercial Distribution
Brand NameWN Plastic coping for WN Solid abutments, crown
Version Model Number090100
Company DUNS527603266
Company NameBIO CONCEPT 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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106947600302537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600302537]

Moist Heat or Steam Sterilization


[06947600302537]

Moist Heat or Steam Sterilization


[06947600302537]

Moist Heat or Steam Sterilization


[06947600302537]

Moist Heat or Steam Sterilization


[06947600302537]

Moist Heat or Steam Sterilization


[06947600302537]

Moist Heat or Steam Sterilization


[06947600302537]

Moist Heat or Steam Sterilization


[06947600302537]

Moist Heat or Steam Sterilization


[06947600302537]

Moist Heat or Steam Sterilization


[06947600302537]

Moist Heat or Steam Sterilization


[06947600302537]

Moist Heat or Steam Sterilization


[06947600302537]

Moist Heat or Steam Sterilization


[06947600302537]

Moist Heat or Steam Sterilization


[06947600302537]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-19
Device Publish Date2016-09-01

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