AIR-FLOW EL-354HF/C

GUDID 07613353002480

PERIO-FLOW Handpiece White

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

Dental abrasive air jet system

• Primary Device ID: 07613353002480
• NIH Device Record Key: baf744d8-a10f-4000-aad8-b4a2e0620570
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIR-FLOW
• Version Model Number: B
• Catalog Number: EL-354HF/C
• 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: true
• Serial Number: false
• 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	07613353002480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110173

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[07613353002480]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [AIR-FLOW]

• 07613353172336: AIR-FLOW MASTER Perio
• 07613353172329: AIR-FLOW MASTER Perio
• 07613353172282: AIR-FLOW S1
• 07613353172275: AIR-FLOW S1
• 07613353172015: AIR-FLOW® handy 3.0 PERIO
• 07613353172008: AIR-FLOW® handy 3.0 PERIO
• 07613353171995: AIR-FLOW® handy 3.0 PERIO
• 07613353171988: AIR-FLOW® handy 3.0 PERIO
• 07613353171971: AIR-FLOW® handy 3.0 PERIO
• 07613353171964: AIR-FLOW® handy 3.0 PERIO
• 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