13 MM IC STD NON-EXPANDABLE IMPLANT

GUDID 00852550007271

Bio-Dent, Inc.

Screw endosteal dental implant, one-piece
Primary Device ID00852550007271
NIH Device Record Key5d987ba5-4786-4307-8655-9f9f1bcfd7ee
Commercial Distribution StatusIn Commercial Distribution
Brand Name13 MM IC STD NON-EXPANDABLE IMPLANT
Version Model Number3813I
Company DUNS017725036
Company NameBio-Dent, Inc.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Height13 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100852550007271 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-22

Devices Manufactured by Bio-Dent, Inc.

00852550007165 - 8mm ULTRA TOOTH SOLID WIDE IMPLANT2018-07-06
00852550007172 - 10 MM ULTRA TOOTH SOLID WIDE IMPLANT2018-07-06
00852550007189 - 13 MM ULTRA TOOTH SOLID WIDE IMPLANT2018-07-06
00852550007196 - 16 MM ULTRA TOOTH SOLID WIDE IMPLANT2018-07-06
00852550007202 - 8 MM ULTRA TOOTH IMPLANT2018-07-06
00852550007219 - 10 MM ULTRA TOOTH IMPLANT2018-07-06
00852550007226 - 13 MM ULTRA TOOTH IMPLANT2018-07-06
00852550007233 - 16 MM ULTRA TOOTH IMPLANT2018-07-06

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