AIR-FLOW FT-221#NA/006

GUDID 07613353223793

AIR-FLOW® handy 3.0 PERIO

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

Dental abrasive air jet system handpiece

• Primary Device ID: 07613353223793
• NIH Device Record Key: 14492de0-7ca4-4cff-b7b2-71aea02e38a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIR-FLOW
• Version Model Number: B
• Catalog Number: FT-221#NA/006
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 85 Percent (%) Relative Humidity and 510 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 85 Percent (%) Relative Humidity and 510 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 85 Percent (%) Relative Humidity and 510 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 85 Percent (%) Relative Humidity and 510 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 85 Percent (%) Relative Humidity and 510 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 85 Percent (%) Relative Humidity and 510 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 85 Percent (%) Relative Humidity and 510 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 85 Percent (%) Relative Humidity and 510 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 85 Percent (%) Relative Humidity and 510 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 85 Percent (%) Relative Humidity and 510 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613353223793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132480

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

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: 2022-08-04
• Device Publish Date: 2022-07-27

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• 07613353172015: AIR-FLOW® handy 3.0 PERIO
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• 07613353171957: AIR-FLOW® handy 3.0 PERIO
• 07613353171940: AIR-FLOW® handy 3.0 PERIO
• 07613353171933: AIR-FLOW® handy 3.0 PERIO
• 07613353171926: AIR-FLOW® handy 3.0 PERIO
• 07613353171919: AIR-FLOW® handy 3.0 PERIO
• 07613353171902: AIR-FLOW® handy 3.0 PERIO
• 07613353171896: AIR-FLOW® handy 3.0 PERIO Adapter X / PERIO or PLUS handpiece
• 07613353171889: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter KaVo
• 07613353171872: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter Sirona
• 07613353171865: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter W&H
• 07613353171858: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter BienAir
• 07613353171841: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter NSK N2
• 07613353171834: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter Midwest
• 07613353171827: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter X
• 07613353171810: AIR-FLOW® handy 3.0 Adapter NSK N2
• 07613353171803: AIR-FLOW® handy 3.0 Adaptateur W&H
• 07613353171797: AIR-FLOW® handy 3.0 Adaptateur KaVo
• 07613353171780: AIR-FLOW® handy 3.0 Adapter Midwest
• 07613353171773: AIR-FLOW® handy 3.0 Adapter Midwest
• 07613353171766: AIR-FLOW® handy 3.0 Adapter Sirona
• 07613353171759: AIR-FLOW® handy 3.0 Adapter KaVo
• 07613353171742: AIR-FLOW® handy 3.0 Adaptateur NSK N2
• 07613353171735: AIR-FLOW® handy 3.0 Adapter BienAir
• 07613353171728: AIR-FLOW® handy 3.0 Adapter Sirona
• 07613353171711: AIR-FLOW® handy 3.0 Adapter BienAir
• 07613353171704: AIR-FLOW® handy 3.0 Adapter W&H
• 07613353171698: AIR-FLOW® handy 3.0 Adapter x
• 07613353170189: 4x40 PERIO-FLOW nozzles
• 07613353170165: 40 PERIO-FLOW nozzles
• 07613353168537: AIR-FLOW® PLUS handy 3.0 PERIO handpiece
• 07613353168513: AIR-FLOW handy 3.0 handpiece
• 07613353168261: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter KaVo
• 07613353168254: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter Sirona
• 07613353168247: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter W&H
• 07613353168230: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter BienAir
• 07613353168223: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter NSK N2
• 07613353168216: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter Midwest
• 07613353168209: AIR-FLOW® handy 3.0 PERIO / PLUS Premium Adapter X
• 07613353168131: AIR-FLOW® handy 3.0 PERIO
• 07613353168124: AIR-FLOW® handy 3.0 PERIO