Stage 1 Implant System RSW5512-3K

GUDID D768RSW55123K0

Implant

KEYSTONE DENTAL, INC.

Screw endosteal dental implant, two-piece
Primary Device IDD768RSW55123K0
NIH Device Record Key5fe2206d-dc94-409b-bf29-c31764b0c3e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameStage 1 Implant System
Version Model NumberRSW5512-3K
Catalog NumberRSW5512-3K
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
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
HIBCCD768RSW55123K0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[D768RSW55123K0]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-01-29

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D768RSW55103K0Implant
D768RSW55102K0Implant
D768RSW55083K0Implant
D768RSW55082K0Implant
D768RSW48142K0Implant
D768RSW48123K0Implant
D768RSW48122K0Implant
D768RSW48103K0Implant
D768RSW48102K0Implant
D768RSW48083K0Implant
D768RSW48082K0Implant
D768RSR48162K0Implant
D768RSR48143K0Implant
D768RSR48142K0Implant
D768RSR48123K0Implant
D768RSR48122K0Implant
D768RSR48103K0Implant
D768RSR48102K0Implant
D768RSR48083K0Implant
D768RSR48082K0Implant
D768RSR41163K0Implant
D768RSR41162K0Implant
D768RSR41143K0Implant
D768RSR41142K0Implant
D768RSR41123K0Implant
D768RSR41122K0Implant
D768RSR41103K0Implant
D768RSR41102K0Implant
D768RSR41083K0Implant
D768RSR41082K0Implant
D768RSR33143K0Implant
D768RSR33142K0Implant
D768RSR33123K0Implant
D768RSR33122K0Implant
D768RSR33103K0Implant
D768RSR33102K0Implant
D768RSR33083K0Implant
D768RSR33082K0Implant

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