INTRA LUX KL 703 LED Planmeca 1.015.0960

GUDID EKAV101509600

KaVo Dental GmbH

Dental surgical power tool motor, electric

• Primary Device ID: EKAV101509600
• NIH Device Record Key: 22c18679-c893-4bee-99cd-8cae41233576
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRA LUX KL 703 LED Planmeca
• Version Model Number: 1.015.0960
• Catalog Number: 1.015.0960
• 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: 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101509600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103027

FDA Product Code

• EKX: Handpiece, direct drive, ac-powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-24
• Device Publish Date: 2023-04-14

Devices Manufactured by KaVo Dental GmbH

• EKAV101537000 - DIAGNOcam Vision Full HD: 2024-12-11
• EKAV101112130 - DIAGNOcam Vision Full HD: 2024-02-09
• EKAV101315000 - DIAGNOcam Vision Full HD: 2024-02-09
• EKAV101402800 - MASTERmatic LUX M45 L: 2024-02-09
• 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
• EKAV101509600 - INTRA LUX KL 703 LED Planmeca: 2023-04-24
• EKAV101509600 - INTRA LUX KL 703 LED Planmeca: 2023-04-24
• EKAV100703380 - Prophylaxe Set 2008: 2022-08-16 This is a medical device.
• EKAV200009220 - PROPHYflex perio tip: 2022-08-16 This is a medical Device.