Retentive Anchor Abutment

GUDID 06947600301172

BIO CONCEPT CO.,LTD

Dental implant system
Primary Device ID06947600301172
NIH Device Record Key6fa36772-b0fe-45c7-8ba9-98e1475f732f
Commercial Distribution StatusIn Commercial Distribution
Brand NameRetentive Anchor Abutment
Version Model Number032040
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
GS106947600301172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600301172]

Moist Heat or Steam Sterilization


[06947600301172]

Moist Heat or Steam Sterilization


[06947600301172]

Moist Heat or Steam Sterilization


[06947600301172]

Moist Heat or Steam Sterilization


[06947600301172]

Moist Heat or Steam Sterilization


[06947600301172]

Moist Heat or Steam Sterilization


[06947600301172]

Moist Heat or Steam Sterilization


[06947600301172]

Moist Heat or Steam Sterilization


[06947600301172]

Moist Heat or Steam Sterilization


[06947600301172]

Moist Heat or Steam Sterilization


[06947600301172]

Moist Heat or Steam Sterilization


[06947600301172]

Moist Heat or Steam Sterilization


[06947600301172]

Moist Heat or Steam Sterilization


[06947600301172]

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

Devices Manufactured by BIO CONCEPT CO.,LTD

06947600316596 - BV Guided Kit,BV2024-09-26
06947600319016 - Anchor Drill,Φ1.3mm,L33mm2024-09-26
06947600319030 - Initial Drill,Φ3.5mm/Φ5.7mm,L5mm2024-09-26
06947600319047 - Initial Drill,Φ2.7mm/Φ5mm,L5mm2024-09-26
06947600319054 - Initial Drill,Φ3.5mm/Φ5mm,L5mm2024-09-26
06947600319061 - Initial Drill,Φ2.7mm/Φ5mm,L7mm2024-09-26
06947600319078 - Initial Drill,Φ2.7mm/Φ5mm,L8.5mm2024-09-26
06947600319085 - Initial Drill,Φ2.7mm/Φ5mm,L10mm2024-09-26

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