RN Impression Post for closed-tray impression

GUDID 06947600304562

BIO CONCEPT Co., Ltd.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID06947600304562
NIH Device Record Key3618f461-9e32-4f72-80a5-c541e2ea49e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameRN Impression Post for closed-tray impression
Version Model Number062160
Company DUNS527603266
Company NameBIO CONCEPT Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS106947600304562 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06947600304562]

Moist Heat or Steam Sterilization


[06947600304562]

Moist Heat or Steam Sterilization


[06947600304562]

Moist Heat or Steam Sterilization


[06947600304562]

Moist Heat or Steam Sterilization


[06947600304562]

Moist Heat or Steam Sterilization


[06947600304562]

Moist Heat or Steam Sterilization


[06947600304562]

Moist Heat or Steam Sterilization


[06947600304562]

Moist Heat or Steam Sterilization


[06947600304562]

Moist Heat or Steam Sterilization


[06947600304562]

Moist Heat or Steam Sterilization


[06947600304562]

Moist Heat or Steam Sterilization


[06947600304562]

Moist Heat or Steam Sterilization


[06947600304562]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-02
Device Publish Date2025-03-25

Devices Manufactured by BIO CONCEPT Co., Ltd.

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06936616987746 - Dome Drill,Φ7.0mm, L25mm2025-04-02
06936616987753 - Dome Drill,Φ7.0mm, L26mm2025-04-02
06936616987760 - Osteotome maxillary sinus elevation Drill,Φ2.8mm, L31mm2025-04-02
06936616987777 - Osteotome maxillary sinus elevation Drill,Φ2.8mm, L37mm2025-04-02
06936616987784 - Osteotome maxillary sinus elevation Drill,Φ3.1mm, L31mm2025-04-02
06936616987791 - Osteotome maxillary sinus elevation Drill,Φ3.1mm, L37mm2025-04-02
06936616987807 - Osteotome maxillary sinus elevation Drill,Φ3.3mm, L31mm2025-04-02

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