Ball Analog

GUDID 08800011265571

POINTIMPLANT Co., Ltd.

Dental implant analog
Primary Device ID08800011265571
NIH Device Record Key7e0c4cbe-b950-4550-8c80-1113df2e3f99
Commercial Distribution StatusIn Commercial Distribution
Brand NameBall Analog
Version Model NumberOSBLA400
Company DUNS695333960
Company NamePOINTIMPLANT Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800011265571 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


[08800011265571]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-02
Device Publish Date2025-05-23

Devices Manufactured by POINTIMPLANT Co., Ltd.

08800011264819 - Tissue Punch Drill2025-06-02
08800011264840 - Point Drill2025-06-02
08800011265571 - Ball Analog2025-06-02
08800011265571 - Ball Analog2025-06-02
08800011265588 - Initial Drill2025-06-02
08800011265762 - Vertical Anchor2025-06-02
08800011265823 - Initial Drill2025-06-02
08800011265830 - Initial Drill2025-06-02
08800011265847 - Initial Drill2025-06-02

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