Park Dental Research Corporation CASE-4

GUDID D769CASE40

Lew MDI Case

PARK DENTAL RESEARCH CORP

Surgical instrument/implant rack
Primary Device IDD769CASE40
NIH Device Record Keyb86ba2d9-7d35-420c-93d1-173f0afba616
Commercial Distribution StatusIn Commercial Distribution
Brand NamePark Dental Research Corporation
Version Model NumberCASE-4
Catalog NumberCASE-4
Company DUNS011441508
Company NamePARK DENTAL RESEARCH CORP
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD769CASE40 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D769CASE40]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-14
Device Publish Date2018-11-13

On-Brand Devices [Park Dental Research Corporation]

D769XP501605.0 mm x 16 mm XP StarVent Implant w/ Cover Screw
D769XP501305.0 mm x 13 mm XP StarVent Implant w/ Cover Screw
D769XP501105.0 mm x 11 mm XP StarVent Implant w/ Cover Screw
D769XP501005.0 mm x 10 mm XP StarVent Implant w/ Cover Screw
D769XP500805.0 mm x 08 mm XP StarVent Implant w/ Cover Screw
D769XP421604.2 mm x 16 mm XP StarVent Implant w/ Cover Screw
D769XP421304.2 mm x 13 mm XP StarVent Implant w/ Cover Screw
D769XP421104.2 mm x 11 mm XP StarVent Implant w/ Cover Screw
D769XP421004.2 mm x 10 mm XP StarVent Implant w/ Cover Screw
D769XP420804.2 mm x 08 mm XP StarVent Implant w/ Cover Screw
D769XP381603.75 mm x 16 mm XP StarVent Implant w/ Cover Screw
D769XP381303.75 mm x 13 mm XP StarVent Implant w/ Cover Screw
D769XP381103.75 mm x 11 mm XP StarVent Implant w/ Cover Screw
D769XP381003.75 mm x 10 mm XP StarVent Implant w/ Cover Screw
D769XP380803.75 mm x 08 mm XP StarVent Implant w/ Cover Screw
D769XP331603.3 mm x 16 mm XP StarVent Implant w/ Cover Screw
D769XP331303.3 mm x 13 mm XP StarVent Implant w/ Cover Screw
D769CASE40Lew MDI Case
D769CASE30Multi System Case
D769BNC10Bone Caliper

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