PROPHY AIRLITE 4-HOLE

GUDID D82650250030

The Prophy Airlite is a 4-HOLE pneumatic dental handpiece which accepts prophy angles, has premium ball bearings, and operates at a speed of 3500 RPMs. It is used for polishing teeth and used by professional hygienists and dentists in a dental setting.

MTI Precision Products, LLC

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• Primary Device ID: D82650250030
• NIH Device Record Key: edfd8bfc-86be-4f7a-918b-5d664916f52f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROPHY AIRLITE 4-HOLE
• Version Model Number: 5025003
• Company DUNS: 081600128
• Company Name: MTI Precision Products, LLC
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8265025003 [Primary]
HIBCC	D82650250030 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940261

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

[D82650250030]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-20
• Device Publish Date: 2023-02-10

On-Brand Devices [PROPHY AIRLITE 4-HOLE]

• D82650250060: The Prophy Airlite is a 4-HOLE pneumatic dental handpiece which accepts prophy angles, has premi
• D82650250030: The Prophy Airlite is a 4-HOLE pneumatic dental handpiece which accepts prophy angles, has premi