INNO Submerged Implant System-Absolute Abutment

GUDID 08809471722365

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 ID08809471722365
NIH Device Record Key268b1ace-02b2-48c6-9f35-f3826db969fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameINNO Submerged Implant System-Absolute Abutment
Version Model Number2SAC6545
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
GS108809471722365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809471722365]

Moist Heat or Steam Sterilization


[08809471722365]

Moist Heat or Steam Sterilization


[08809471722365]

Moist Heat or Steam Sterilization


[08809471722365]

Moist Heat or Steam Sterilization


[08809471722365]

Moist Heat or Steam Sterilization


[08809471722365]

Moist Heat or Steam Sterilization


[08809471722365]

Moist Heat or Steam Sterilization


[08809471722365]

Moist Heat or Steam Sterilization


[08809471722365]

Moist Heat or Steam Sterilization


[08809471722365]

Moist Heat or Steam Sterilization


[08809471722365]

Moist Heat or Steam Sterilization


[08809471722365]

Moist Heat or Steam Sterilization


[08809471722365]

Moist Heat or Steam Sterilization


[08809471722365]

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-Absolute Abutment]

088094717230272SACW547N
088094717230102SACW537N
088094717230032SACW527N
088094717229902SACW517N
088094717229832SACW545
088094717229762SACW535
088094717229692SACW525
088094717229522SACW515
088094717229452SACW544
088094717229382SACW534
088094717229212SACW524
088094717229142SACW514
088094717229072SACR447N
088094717228912SACR437N
088094717228842SACR427N
088094717228772SACR417N
088094717228602SACR445
088094717228532SACR435
088094717228462SACR425
088094717228392SACR415
088094717228222SACR444
088094717228152SACR434
088094717228082SACR424
088094717227922SACR414
088094717224262SAC6557
088094717224192SAC6547
088094717224022SAC6537
088094717223962SAC6527
088094717223892SAC6517
088094717223722SAC6555
088094717223652SAC6545
088094717223582SAC6535
088094717223412SAC6525
088094717223342SAC6515
088094717223272SAC6554
088094717223102SAC6544
088094717223032SAC6534
088094717222972SAC6524
088094717222802SAC6514
088094717222732SAC5557
088094717222662SAC5547
088094717222592SAC5537
088094717222422SAC5527
088094717222352SAC5517
088094717222282SAC5555
088094717222112SAC5545
088094717222042SAC5535
088094717221982SAC5525
088094717221812SAC5515
088094717221742SAC5554

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