Zircasso

GUDID 04710986431373

One piece zirconia dental implant. Diameter : 5.1 mm, Length : 14 mm

COHO BIOMEDICAL TECHNOLOGY CO., LTD.

Dental implant system
Primary Device ID04710986431373
NIH Device Record Key19f6eab9-ae7e-410e-8e2a-3e01524f1080
Commercial Distribution StatusIn Commercial Distribution
Brand NameZircasso
Version Model NumberZCS-I5114
Company DUNS658658526
Company NameCOHO BIOMEDICAL TECHNOLOGY 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104710986431373 [Primary]

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 Date2019-10-31
Device Publish Date2019-10-23

On-Brand Devices [Zircasso]

04710986431373One piece zirconia dental implant. Diameter : 5.1 mm, Length : 14 mm
04710986431366One piece zirconia dental implant. Diameter : 5.1 mm, Length : 12 mm
04710986431359One piece zirconia dental implant. Diameter : 5.1 mm, Length : 10 mm
04710986431342One piece zirconia dental implant. Diameter : 5.1 mm, Length : 8 mm
04710986431335One piece zirconia dental implant. Diameter : 4.1 mm, Length : 14 mm
04710986431328One piece zirconia dental implant. Diameter : 4.1 mm, Length : 12 mm
04710986431311One piece zirconia dental implant. Diameter : 4.1 mm, Length : 10 mm
04710986431304One piece zirconia dental implant. Diameter : 4.1 mm, Length : 8 mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.