Park Dental Research Corporation

GUDID D769XP38080

3.75 mm x 08 mm XP StarVent Implant w/ Cover Screw

PARK DENTAL RESEARCH CORP

Screw endosteal dental implant, two-piece
Primary Device IDD769XP38080
NIH Device Record Keyc22631da-f982-4946-a4b2-802a47811cce
Commercial Distribution StatusIn Commercial Distribution
Brand NamePark Dental Research Corporation
Version Model NumberXP3808
Company DUNS011441508
Company NamePARK DENTAL RESEARCH CORP
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-243-7372
Emailinfo@pdrus.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD769XP38080 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-14
Device Publish Date2018-11-13

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