StarDental Instrument Solutions

GUDID D7022658220

430 SW 45 HANDPIECE (NON-FIBER OPTIC)

DENTALEZ, INC.

Dental surgical power tool motorized handpiece/set, pneumatic

• Primary Device ID: D7022658220
• NIH Device Record Key: 01599c50-3a00-4e5d-a6da-a7d3ceca4a50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StarDental Instrument Solutions
• Version Model Number: 265822
• Company DUNS: 059010363
• Company Name: DENTALEZ, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx
• Phone: 1-866-383-4636
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7022658220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130455

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

[D7022658220]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-22
• Device Publish Date: 2018-11-05

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• D7022003140: CLASSIQUE DIA INSTRUMENTS 700-10P
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• D7022688440: HIFLO 6-PIN SWIVEL, 3.3V SATIN, LED
• D7022661000: Titan EX Motor 20K, 2-Line
• D702265718Y0: SOLARA QT LF FO HP GOLD COLLAR
• D702265718G0: SOLARA QT LF FO HP GREEN COLLAR
• D702265718F0: SOLARA QT LF FO HP FUCHSIA COLLAR
• D7022641690: PERIO SCALER TIP - 100/BAG
• D7022641660: SICKLE SCALER TIP - 100/BAG
• D7022641520: UNIVERSAL TIP - 100/BAG
• D7022634850: SENSITIP KIT
• D7022027250: INSTR MG DE JAQU 2Y-3Y
• D7022024050: INSTR MG SE SPREADER MA57
• D7022023970: INSTR MG SE SPREADER 3
• D7022020890: INSTR MG SE EXPL 6-1/2
• D7022020850: INSTR MG SE EXPLORER 6
• D7022020590: INSTR PKGD 33L EXCAVATOR
• D7022019410: INSTR MG DE MCCAL 17S-18S
• D7022019320: INSTR MG DE GOLDMAN-FOX 4
• D7022019100: INSTR MG DE GRACEY 3-4
• D7022633980: Titan Scaler Tip - Right Perio
• D7022633970: TITAN SCALER TIP, LEFT PERIO
• D7022616690: TITAN SCALER TIP - PERIO
• D7022616680: TITAN SCALER TIP- UNIVERSAL
• D7022616670: TITAN SCALER TIP - SICKLE
• D7022659960: ISTAR PROPHY BOX 500 SLEEVES
• D7022004960: CLASSIQUE DIA INSTRUMENTS 774-7P
• D7022004830: CLASSIQUE DIA INSTRUMENTS 772-10P
• D7022004780: CLASSIQUE DIA INSTRUMENTS 772-9P
• D7022004730: CLASSIQUE DIA INSTRUMENTS 772-8P
• D7022004680: CLASSIQUE DIA INSTRUMENTS 772-7P
• D7022004480: CLASSIQUE DIA INSTRUMENTS 771-8P
• D7022004330: CLASSIQUE DIA INSTRUMENTS 770-10P
• D7022004280: CLASSIQUE DIA INSTRUMENTS 770-9P
• D7022004230: CLASSIQUE DIA INSTRUMENTS 770-8P
• D7022004180: CLASSIQUE DIA INSTRUMENTS 770-7P
• D7022004150: CLASSIQUE DIA INSTRUMENTS 769-13P
• D7022004020: CLASSIQUE DIA INSTRUMENTS 769-10P
• D7022003940: CLASSIQUE DIA INSTRUMENTS 769-9P
• D7022003540: CLASSIQUE DIA INSTRUMENTS 702-8P
• D7022003390: CLASSIQUE DIA INSTRUMENTS 701-10P
• D7022003290: CLASSIQUE DIA INSTRUMENTS 701-8P
• D7022003030: CLASSIQUE DIA INSTRUMENTS 700-8P
• D7022002950: CLASSIQUE DIA INSTRUMENTS 699-11P
• D7022002880: CLASSIQUE DIA INSTRUMENTS 699-9P
• D7022002760: CLASSIQUE DIA INSTRUMENTS 558-7P
• D7022002720: CLASSIQUE DIA INSTRUMENTS 557-7P