OT-F2 Implant 02-1382080010

GUDID EOTM0213820800101

Dental Implant, Screw, made by Titanium, Diameter: 3,8 mm, Length: 8 mm

OT medical GmbH

Screw endosteal dental implant, one-piece
Primary Device IDEOTM0213820800101
NIH Device Record Keya4b04292-e60d-4e0b-bc20-27c03a4567e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameOT-F2 Implant
Version Model Number02-1382080010
Catalog Number02-1382080010
Company DUNS340998796
Company NameOT medical GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
HIBCCEOTM0213820800101 [Primary]

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-15

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EOTM0213421600101Dental Implant, Screw, made by Titanium, Diameter: 3,4 mm, Length: 16 mm
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EOTM0213421200101Dental Implant, Screw, made by Titanium, Diameter: 3,4 mm, Length: 12 mm
EOTM0213421000101Dental Implant, Screw, made by Titanium, Diameter: 3,4 mm, Length: 10 mm
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