Genesis Implant System G21152

GUDID D768G211520

Implant

KEYSTONE DENTAL, INC.

Screw endosteal dental implant, two-piece
Primary Device IDD768G211520
NIH Device Record Keya96c6854-88cc-4cdc-8eca-817b0da0686f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenesis Implant System
Version Model NumberG21152
Catalog NumberG21152
Company DUNS787471015
Company NameKEYSTONE DENTAL, INC.
Device Count1
DM Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com
Phone+1(866)902-9272
Emailinfo@keystonedental.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD768G211520 [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 Number4
Public Version Date2021-03-31
Device Publish Date2016-01-29

On-Brand Devices [Genesis Implant System]

D768G211530Implant
D768G211520Implant
D768G211510Implant
D768G211500Implant
D768G211470Implant
D768G211460Implant
D768G211450Implant
D768G211440Implant
D768G211420Implant
D768G211400Implant
D768G211390Implant
D768G211380Implant
D768G211370Implant
D768G211350Implant
D768G211330Implant
D768G211320Implant
D768G211310Implant
D768G211300Implant
D768G210530Implant
D768G210520Implant
D768G210510Implant
D768G210500Implant

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