REBORN Fixture

GUDID 08800023151558

Cybermed Inc.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID08800023151558
NIH Device Record Key148cba25-6000-42f6-a991-1e00512fc576
Commercial Distribution StatusIn Commercial Distribution
Brand NameREBORN Fixture
Version Model NumberIC1M3513SC
Company DUNS688248447
Company NameCybermed Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+827051187131
Emailkshwan95@cybermed.co.kr
Phone+827051187131
Emailkshwan95@cybermed.co.kr
Phone+827051187131
Emailkshwan95@cybermed.co.kr
Phone+827051187131
Emailkshwan95@cybermed.co.kr
Phone+827051187131
Emailkshwan95@cybermed.co.kr
Phone+827051187131
Emailkshwan95@cybermed.co.kr
Phone+827051187131
Emailkshwan95@cybermed.co.kr

Device Identifiers

Device Issuing AgencyDevice ID
GS108800023151558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-10
Device Publish Date2022-11-02

On-Brand Devices [REBORN Fixture]

08800023152210IC1R4513OC
08800023152203IC1R4511OC
08800023152197IC1R4510OC
08800023152180IC1R4508OC
08800023152173IC1R4507OC
08800023152166IC1R4013OC
08800023152159IC1R4011OC
08800023152142IC1R4010OC
08800023152135IC1R4008OC
08800023152128IC1R4007OC
08800023152111IC1M3513OC
08800023152104IC1M3511OC
08800023152098IC1M3510OC
08800023152081IC1M3508OC
08800023151794IC1R5013C
08800023151787IC1R5011C
08800023151770IC1R5010C
08800023151763IC1R5008C
08800023151756IC1R5007C
08800023151749IC1R4513C
08800023151732IC1R4511C
08800023151725IC1R4510C
08800023151718IC1R4508C
08800023151701IC1R4507C
08800023151695IC1R4013C
08800023151688IC1R4011C
08800023151671IC1R4010C
08800023151664IC1R4008C
08800023151657IC1R4007C
08800023151640IC1R4013SC
08800023151633IC1R4011SC
08800023151626IC1R4010SC
08800023151619IC1R4008SC
08800023151602IC1R4007SC
08800023151596IC1M3513C
08800023151589IC1M3511C
08800023151572IC1M3510C
08800023151565IC1M3508C
08800023151541IC1M3511SC
08800023151534IC1M3510SC
08800023151527IC1M3508SC
08800023151510IC1M3013C
08800023151503IC1M3011C
08800023151497IC1M3010C
08800023151480IC1M3008C
08800023151558IC1M3513SC

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