INNO Submerged Implant System-Cemented Abutment

GUDID 08809471720804

Cowellmedi Co.,Ltd

Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw
Primary Device ID08809471720804
NIH Device Record Keybf96e5c6-1911-44cd-b9c6-aeea583045da
Commercial Distribution StatusIn Commercial Distribution
Brand NameINNO Submerged Implant System-Cemented Abutment
Version Model Number2SCNR434
Company DUNS688753763
Company NameCowellmedi 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
GS108809471720804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809471720804]

Moist Heat or Steam Sterilization


[08809471720804]

Moist Heat or Steam Sterilization


[08809471720804]

Moist Heat or Steam Sterilization


[08809471720804]

Moist Heat or Steam Sterilization


[08809471720804]

Moist Heat or Steam Sterilization


[08809471720804]

Moist Heat or Steam Sterilization


[08809471720804]

Moist Heat or Steam Sterilization


[08809471720804]

Moist Heat or Steam Sterilization


[08809471720804]

Moist Heat or Steam Sterilization


[08809471720804]

Moist Heat or Steam Sterilization


[08809471720804]

Moist Heat or Steam Sterilization


[08809471720804]

Moist Heat or Steam Sterilization


[08809471720804]

Moist Heat or Steam Sterilization


[08809471720804]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-22
Device Publish Date2016-10-28

On-Brand Devices [INNO Submerged Implant System-Cemented Abutment]

088094717219792SCN6557
088094717219622SCN6547
088094717219552SCN6537
088094717219482SCN6527
088094717219312SCN6517
088094717219242SCN6555
088094717219172SCN6545
088094717219002SCN6535
088094717218942SCN6525
088094717218872SCN6515
088094717218702SCN6554
088094717218632SCN6544
088094717218562SCN6534
088094717218492SCN6524
088094717218322SCN6514
088094717218252SCN5557
088094717218182SCN5547
088094717218012SCN5537
088094717217952SCN5527
088094717217882SCN5517
088094717217712SCN5555
088094717217642SCN5545
088094717217572SCN5535
088094717217402SCN5525
088094717217332SCN5515
088094717217262SCN5554
088094717217192SCN5544
088094717217022SCN5534
088094717216962SCN5524
088094717216892SCN5514
088094717216722SCN4557
088094717216652SCN4547
088094717216582SCN4537
088094717216412SCN4527
088094717216342SCN4517
088094717216272SCN4555
088094717216102SCN4545
088094717216032SCN4535
088094717215972SCN4525
088094717215802SCN4515
088094717215732SCN4554
088094717215662SCN4544
088094717215592SCN4534
088094717215422SCN4524
088094717215352SCN4514
088094717215282SCH6557
088094717215112SCH6547
088094717215042SCH6537
088094717214982SCH6527
088094717214812SCH6517

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