PIEZON EN-061/A

GUDID 07613353136468

Piezon Handpiece

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

Ultrasonic dental scaling/debridement system

• Primary Device ID: 07613353136468
• NIH Device Record Key: c3c25377-1fc1-45d6-a47c-1c69d0d3e94b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIEZON
• Version Model Number: F
• Catalog Number: EN-061/A
• 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: 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613353136468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093000

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

[07613353136468]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-21
• Device Publish Date: 2018-11-20

On-Brand Devices [PIEZON]

• 07613353172442: PIEZON® 250
• 07613353172435: PIEZON® 250
• 07613353172428: PIEZON® 250
• 07613353172411: PIEZON® 150
• 07613353172404: PIEZON® 150
• 07613353172398: PIEZON® 150
• 07613353172350: PIEZON MASTER 700
• 07613353172343: PIEZON MASTER 700
• 07613353169275: E
• 07613353168568: Universal Piezon Handpiece
• 07613353168193: PIEZON® 250
• 07613353168186: PIEZON® 250
• 07613353168179: PIEZON® 250
• 07613353168162: PIEZON® 150
• 07613353168155: PIEZON® 150
• 07613353168148: PIEZON® 150
• 07613353167844: PIEZON MASTER 700
• 07613353167837: PIEZON MASTER 700
• 07613353166052: The Piezon handpiece is an accessory in the Piezo-ceramic systems for dentistry.
• 07613353166045: PIEZON Handpiece LED
• 07613353141363: miniMaster
• 07613353141127: miniMaster
• 07613353136482: Piezon Handpiece
• 07613353136468: Piezon Handpiece
• 07613353136451: PIEZON Handpiece LED
• 07613353132804: Piezon Handpiece
• 07613353132774: PIEZON Handpiece LED
• 07613353132750: PIEZON Handpiece LED
• 07613353121846: PIEZON 250
• 07613353121822: PIEZON 250
• 07613353121761: PIEZON 150
• 07613353121716: PIEZON Handpiece LED
• 07613353112318: PIEZON 250
• 07613353112301: PIEZON 150
• 07613353111564: PIEZON 707 BIK LED - A-dec
• 07613353101046: CombiTorque
• 07613353101039: CombiTorque
• 07613353100216: PIEZON® 250
• 07613353100209: PIEZON® 250
• 07613353100193: PIEZON® 250
• 07613353100094: PIEZON® 150
• 07613353100087: PIEZON® 150
• 07613353100070: PIEZON® 150
• 07613353098469: PIEZON 250
• 07613353098360: PIEZON 150
• 07613353095543: PIEZON Handpiece LED
• 07613353095482: Instrument SB with CombiTorque
• 07613353095468: Instrument PL1
• 07613353089375: PIEZON 707 BIK LED - A-dec
• 07613353089078: Kit Piezon OMS