StarDental Instrument Solutions

GUDID D7022654730

1:1 ST ATTACHMENT, ETORQUE

DENTALEZ, INC.

Dental surgical power tool motorized handpiece/set, electric
Primary Device IDD7022654730
NIH Device Record Keyc23ccc4e-5c5d-456b-b606-6ccc68ccaf3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameStarDental Instrument Solutions
Version Model Number265473
Company DUNS059010363
Company NameDENTALEZ, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
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
HIBCCD7022654730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7022654730]

Moist Heat or Steam Sterilization

[D7022654730]

Moist Heat or Steam Sterilization

[D7022654730]

Moist Heat or Steam Sterilization

[D7022654730]

Moist Heat or Steam Sterilization

[D7022654730]

Moist Heat or Steam Sterilization

[D7022654730]

Moist Heat or Steam Sterilization

[D7022654730]

Moist Heat or Steam Sterilization

[D7022654730]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-07-01
Device Publish Date2018-11-05

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D7022008330DIA INSTRUMENTS DY3
D7022003340CLASSIQUE DIA INSTRUMENTS 701-9P
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D7022688600430SWL SATIN LUBRICATED HANDPIECE
D7022688440HIFLO 6-PIN SWIVEL, 3.3V SATIN, LED
D7022661000Titan EX Motor 20K, 2-Line
D702265718Y0SOLARA QT LF FO HP GOLD COLLAR
D702265718G0SOLARA QT LF FO HP GREEN COLLAR
D702265718F0SOLARA QT LF FO HP FUCHSIA COLLAR
D7022641690PERIO SCALER TIP - 100/BAG
D7022641660SICKLE SCALER TIP - 100/BAG
D7022641520UNIVERSAL TIP - 100/BAG
D7022634850SENSITIP KIT
D7022027250INSTR MG DE JAQU 2Y-3Y
D7022024050INSTR MG SE SPREADER MA57
D7022023970INSTR MG SE SPREADER 3
D7022020890INSTR MG SE EXPL 6-1/2
D7022020850INSTR MG SE EXPLORER 6
D7022020590INSTR PKGD 33L EXCAVATOR
D7022019410INSTR MG DE MCCAL 17S-18S
D7022019320INSTR MG DE GOLDMAN-FOX 4
D7022019100INSTR MG DE GRACEY 3-4
D7022633980Titan Scaler Tip - Right Perio
D7022633970TITAN SCALER TIP, LEFT PERIO
D7022616690TITAN SCALER TIP - PERIO
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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