StarDental Instrument Solutions

GUDID D7022004150

CLASSIQUE DIA INSTRUMENTS 769-13P

DENTALEZ, INC.

Diamond dental bur, reusable
Primary Device IDD7022004150
NIH Device Record Key3508d862-8245-4a6e-af72-a250fdb1daf8
Commercial Distribution StatusIn Commercial Distribution
Brand NameStarDental Instrument Solutions
Version Model Number200415
Company DUNS059010363
Company NameDENTALEZ, INC.
Device Count5
DM Exempttrue
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-383-4636
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD702200415 [Unit of Use]
HIBCCD7022004150 [Primary]

FDA Product Code

DZPInstrument, Diamond, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7022004150]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-23
Device Publish Date2018-11-05

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