Refill PROPHYflex perio tip 1.010.0287

GUDID EKAV101002870

PROPHYflex perio tip: Attachment for a focused beam for focused and gentle subgingival treatments as well as cleaning bridges, implants and crowns.

KaVo Dental GmbH

Dental abrasive air jet system handpiece

• Primary Device ID: EKAV101002870
• NIH Device Record Key: e349f736-3362-4a77-b942-3a4a4e764395
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Refill PROPHYflex perio tip
• Version Model Number: 1.010.0287
• Catalog Number: 1.010.0287
• Company DUNS: 333710619
• Company Name: KaVo Dental GmbH
• 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: false
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101002870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181110

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

[EKAV101002870]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-25
• Device Publish Date: 2023-04-17

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• EKAV101002870 - Refill PROPHYflex perio tip: 2023-04-25 PROPHYflex perio tip: Attachment for a focused beam for focused and gentle subgingival treatments as well as cleaning bridges, i
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