StarDental Instrument Solutionss

GUDID D7022688420

HiFlo 6-Pin Swivel, 3.3 Volts Satin

DENTALEZ, INC.

Pneumatic dental handpiece coupler

• Primary Device ID: D7022688420
• NIH Device Record Key: a4308367-b751-4a66-bcc8-897fa839ff57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StarDental Instrument Solutionss
• Version Model Number: 268842
• 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: 1-866383-4636
• Email: xx@xx.xx
• Phone: 1-866383-4636
• Email: xx@xx.xx
• Phone: 1-866383-4636
• Email: xx@xx.xx
• Phone: 1-866383-4636
• Email: xx@xx.xx
• Phone: 1-866383-4636
• Email: xx@xx.xx
• Phone: 1-866383-4636
• Email: xx@xx.xx
• Phone: 1-866383-4636
• Email: xx@xx.xx
• Phone: 1-866383-4636
• Email: xx@xx.xx
• Phone: 1-866383-4636
• Email: xx@xx.xx
• Phone: 1-866383-4636
• Email: xx@xx.xx
• Phone: 1-866383-4636
• Email: xx@xx.xx
• Phone: 1-866383-4636
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7022688420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153411

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[D7022688420]

Moist Heat or Steam Sterilization

[D7022688420]

Moist Heat or Steam Sterilization

[D7022688420]

Moist Heat or Steam Sterilization

[D7022688420]

Moist Heat or Steam Sterilization

[D7022688420]

Moist Heat or Steam Sterilization

[D7022688420]

Moist Heat or Steam Sterilization

[D7022688420]

Moist Heat or Steam Sterilization

[D7022688420]

Moist Heat or Steam Sterilization

[D7022688420]

Moist Heat or Steam Sterilization

[D7022688420]

Moist Heat or Steam Sterilization

[D7022688420]

Moist Heat or Steam Sterilization

[D7022688420]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-10-28
• Device Publish Date: 2018-11-05

Devices Manufactured by DENTALEZ, INC.

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• D7022663450 - StarDental: 2025-06-30 STAR E900 1:1 STRAIGHT HNDPC
• D7022664900 - StarDental: 2025-06-30 STAR E900 1:5 AC, NON FO HANDPIECE
• D7022601520 - StarDental Instrument Solutions: 2025-06-23 TITAN 2-LINE SWIVEL
• D702RT3001050 - StarDental Instrument Solutions: 2025-06-23 Disposable Mirrors 25 Pack
• D7022637580 - StarDental Instrument Solutions: 2024-10-28 HIFLO 4-LINE FO SWIVEL
• D7022637720 - StarDental Instrument Solutions: 2024-10-28 HiFlo 6-Pin Swivel, 3.3 Volts