Kerator Cap

GUDID 08809488213344

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID08809488213344
NIH Device Record Keye3e564ef-7d8d-41a5-acf4-c749678b550d
Commercial Distribution StatusIn Commercial Distribution
Brand NameKerator Cap
Version Model NumberCPB2
Company DUNS688476027
Company NameKJMEDITECH.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 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
GS108809488213344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809488213344]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-08-28

On-Brand Devices [Kerator Cap]

08809488213344CPB2
08809488213337CPP2
08809488213320CPR2
08809488213313CPD2

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