Oct Implant System ITT512

GUDID D768ITT5120

Implant

KEYSTONE DENTAL, INC.

Screw endosteal dental implant, two-piece
Primary Device IDD768ITT5120
NIH Device Record Key10ee3503-115c-4412-b46c-11835fe60d37
Commercial Distribution StatusIn Commercial Distribution
Brand NameOct Implant System
Version Model NumberITT512
Catalog NumberITT512
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(781)328-3515
Emailcyoung@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

Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD768ITT5120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[D768ITT5120]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-02-04

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