GBT Machine AIRFLOW Prophylaxis Master FT-300 2BV02

GUDID 07613353347819

GBT Machine AIRFLOW Prophylaxis Master - GBT Ready

E.M.S. Electro Medical Systems S.A.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 07613353347819
• NIH Device Record Key: b8cb0c5a-2148-4314-85bf-7b82b672ec7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GBT Machine AIRFLOW Prophylaxis Master
• Version Model Number: FT-300
• Catalog Number: FT-300 2BV02
• Company DUNS: 481233849
• Company Name: E.M.S. Electro Medical Systems S.A.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613353347819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253254

FDA Product Code

• ELC: Scaler, Ultrasonic

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: 2026-02-24
• Device Publish Date: 2026-02-16

On-Brand Devices [GBT Machine AIRFLOW Prophylaxis Master]

• 07613353347819: GBT Machine AIRFLOW Prophylaxis Master - GBT Ready
• 07613353347802: GBT Machine AIRFLOW Prophylaxis Master