Fixture Mount

GUDID 08800011260637

POINTIMPLANT Co., Ltd.

Dental implant system
Primary Device ID08800011260637
NIH Device Record Key5eee64a0-f7ee-4648-a770-a5656212e274
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixture Mount
Version Model NumberOFMI
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
GS108800011260637 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800011260637]

Moist Heat or Steam Sterilization


[08800011260637]

Moist Heat or Steam Sterilization


[08800011260637]

Moist Heat or Steam Sterilization


[08800011260637]

Moist Heat or Steam Sterilization


[08800011260637]

Moist Heat or Steam Sterilization


[08800011260637]

Moist Heat or Steam Sterilization


[08800011260637]

Moist Heat or Steam Sterilization


[08800011260637]

Moist Heat or Steam Sterilization


[08800011260637]

Moist Heat or Steam Sterilization


[08800011260637]

Moist Heat or Steam Sterilization


[08800011260637]

Moist Heat or Steam Sterilization


[08800011260637]

Moist Heat or Steam Sterilization


[08800011260637]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-01
Device Publish Date2025-07-24

Devices Manufactured by POINTIMPLANT Co., Ltd.

08800011245764 - Pick-Up Impression Coping2025-08-01
08800011245771 - Pick-Up Impression Coping2025-08-01
08800011245788 - Pick-Up Impression Coping2025-08-01
08800011245795 - Pick-Up Impression Coping2025-08-01
08800011245801 - Pick-Up Impression Coping2025-08-01
08800011245818 - Pick-Up Impression Coping2025-08-01
08800011245825 - Pick-Up Impression Coping2025-08-01
08800011245832 - Pick-Up Impression Coping2025-08-01

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