StarDental Instrument Solutions

GUDID D7022659910

ISTAR PROPHY HANDPIECE (REPLACEMENT)

DENTALEZ, INC.

Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric Dental surgical power tool motorized handpiece/set, electric
Primary Device IDD7022659910
NIH Device Record Key3268b95b-c72d-4d9d-88e8-06e94de366aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameStarDental Instrument Solutions
Version Model Number265991
Company DUNS059010363
Company NameDENTALEZ, 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 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
Phone1-866-383-4636
Emailxx@xx.xx
Phone1-866-383-4636
Emailxx@xx.xx
Phone1-866-383-4636
Emailxx@xx.xx
Phone1-866-383-4636
Emailxx@xx.xx
Phone1-866-383-4636
Emailxx@xx.xx
Phone1-866-383-4636
Emailxx@xx.xx
Phone1-866-383-4636
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7022659910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKXHandpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7022659910]

Moist Heat or Steam Sterilization

[D7022659910]

Moist Heat or Steam Sterilization

[D7022659910]

Moist Heat or Steam Sterilization

[D7022659910]

Moist Heat or Steam Sterilization

[D7022659910]

Moist Heat or Steam Sterilization

[D7022659910]

Moist Heat or Steam Sterilization

[D7022659910]

Moist Heat or Steam Sterilization

[D7022659910]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-06-28
Device Publish Date2018-11-05

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D7022641520UNIVERSAL TIP - 100/BAG
D7022634850SENSITIP KIT
D7022027250INSTR MG DE JAQU 2Y-3Y
D7022024050INSTR MG SE SPREADER MA57
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D7022633970TITAN SCALER TIP, LEFT PERIO
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D7022616680TITAN SCALER TIP- UNIVERSAL
D7022616670TITAN SCALER TIP - SICKLE
D7022659960ISTAR PROPHY BOX 500 SLEEVES
D7022004960CLASSIQUE DIA INSTRUMENTS 774-7P
D7022004830CLASSIQUE DIA INSTRUMENTS 772-10P
D7022004780CLASSIQUE DIA INSTRUMENTS 772-9P
D7022004730CLASSIQUE DIA INSTRUMENTS 772-8P
D7022004680CLASSIQUE DIA INSTRUMENTS 772-7P
D7022004480CLASSIQUE DIA INSTRUMENTS 771-8P
D7022004330CLASSIQUE DIA INSTRUMENTS 770-10P
D7022004280CLASSIQUE DIA INSTRUMENTS 770-9P
D7022004230CLASSIQUE DIA INSTRUMENTS 770-8P
D7022004180CLASSIQUE DIA INSTRUMENTS 770-7P
D7022004150CLASSIQUE DIA INSTRUMENTS 769-13P
D7022004020CLASSIQUE DIA INSTRUMENTS 769-10P
D7022003940CLASSIQUE DIA INSTRUMENTS 769-9P
D7022003540CLASSIQUE DIA INSTRUMENTS 702-8P
D7022003390CLASSIQUE DIA INSTRUMENTS 701-10P
D7022003290CLASSIQUE DIA INSTRUMENTS 701-8P
D7022003030CLASSIQUE DIA INSTRUMENTS 700-8P
D7022002950CLASSIQUE DIA INSTRUMENTS 699-11P
D7022002880CLASSIQUE DIA INSTRUMENTS 699-9P
D7022002760CLASSIQUE DIA INSTRUMENTS 558-7P
D7022002720CLASSIQUE DIA INSTRUMENTS 557-7P
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