Instruments PS PSR PSL

GUDID 07613353180096

Instruments PS PSR PSL

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

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 07613353180096
• NIH Device Record Key: 9aaf18a0-6ce8-480e-abc9-43fad56acdd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instruments PS PSR PSL
• Version Model Number: FS-459
• Company DUNS: 481233849
• Company Name: E.M.S. Electro Medical Systems S.A.
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613353180096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253254

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[07613353180096]

Moist Heat or Steam Sterilization

[07613353180096]

Moist Heat or Steam Sterilization

[07613353180096]

Moist Heat or Steam Sterilization

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

Devices Manufactured by E.M.S. Electro Medical Systems S.A.

• 07613353180089 - Instruments A P PS: 2026-02-24 Instruments A P PS
• 07613353180096 - Instruments PS PSR PSL: 2026-02-24Instruments PS PSR PSL
• 07613353180096 - Instruments PS PSR PSL: 2026-02-24 Instruments PS PSR PSL
• 07613353225940 - GBT FLOWCONTROL x 4: 2026-02-24 GBT FLOWCONTROL x 4
• 07613353313500 - GBT Machine Station: 2026-02-24 GBT Machine Station
• 07613353331184 - GBT Machine Wireless Pedal: 2026-02-24 GBT Machine Wireless Pedal
• 07613353334925 - AIR-FLOW: 2026-02-24 AIRFLOW MAX Handpiece set
• 07613353335847 - AIR-FLOW: 2026-02-24 AIRFLOW MAX Introduction Kit
• 07613353336837 - Instruments PSR PSL: 2026-02-24 Instruments PSR PSL