Premilled Titanium Block System

Abutment, Implant, Dental, Endosseous

InnoBioSurg Co., Ltd.

The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Premilled Titanium Block System.

Pre-market Notification Details

Device IDK203344
510k NumberK203344
Device Name:Premilled Titanium Block System
ClassificationAbutment, Implant, Dental, Endosseous
Applicant InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon,  KR 34027
ContactSun-mi Park
CorrespondentApril Lee
Withus Group Inc 106 Superior Irvine,  CA  92620
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-13
Decision Date2021-08-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800039372916 K203344 000
08800177354737 K203344 000
08800177354744 K203344 000
08800177354751 K203344 000
08800177354768 K203344 000
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08800039373531 K203344 000
08800039373517 K203344 000
08800039373432 K203344 000
08800039372114 K203344 000
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08800177354812 K203344 000
08800177354829 K203344 000
08800177354836 K203344 000
08800177354652 K203344 000
08800177354669 K203344 000
08800177354676 K203344 000
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08800177354690 K203344 000
08800177354706 K203344 000
08800177354713 K203344 000
08800177354720 K203344 000
08800177354645 K203344 000
08800177354638 K203344 000
08800177354621 K203344 000
08800177354843 K203344 000
08800039372237 K203344 000
08800039372312 K203344 000
08800039372336 K203344 000
08800039372411 K203344 000
08800039372435 K203344 000
08800039373296 K203344 000
08800177354614 K203344 000
08800039372091 K203344 000

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