PrimaSolo

GUDID D76815230K0

Implant Driver

KEYSTONE DENTAL, INC.

Surgical screwdriver, reusable
Primary Device IDD76815230K0
NIH Device Record Key4e878008-dfbc-4a47-aad7-26e3f3817a20
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrimaSolo
Version Model Number15230K
Company DUNS787471015
Company NameKEYSTONE DENTAL, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(781)328-3313
Emailsshahid@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 Identifiers

Device Issuing AgencyDevice ID
HIBCCD76815230K0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDPAccessories, implant, dental, endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-16
Device Publish Date2019-05-08

On-Brand Devices [PrimaSolo]

D76815235K0Abutment Try-In Set
D76815230K0Implant Driver
D76815229K0Implant Driver
D76815228K0Implant Driver
D76815227K0Implant Driver
D76815242K0Surgical Kit

Trademark Results [PrimaSolo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRIMASOLO
PRIMASOLO
78531560 3140304 Live/Registered
Keystone Dental, Inc.
2004-12-13

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