PIEZON FT-215#C/005
GUDID 07613353204846
PIEZON 150
E.M.S. Electro Medical Systems S.A.
Ultrasonic dental scaling/debridement system| Primary Device ID | 07613353204846 |
| NIH Device Record Key | d261d3e4-019c-452b-9311-9be64de2a950 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PIEZON |
| Version Model Number | B |
| Catalog Number | FT-215#C/005 |
| 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 |
| udi@ems-ch.com | |
| Phone | +41229944700 |
| udi@ems-ch.com | |
| Phone | +41229944700 |
| udi@ems-ch.com | |
| Phone | +41229944700 |
| udi@ems-ch.com | |
| Phone | +41229944700 |
| udi@ems-ch.com | |
| Phone | +41229944700 |
| udi@ems-ch.com | |
| Phone | +41229944700 |
| udi@ems-ch.com | |
| Phone | +41229944700 |
| udi@ems-ch.com | |
| Phone | +41229944700 |
| udi@ems-ch.com | |
| Phone | +41229944700 |
| 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613353204846 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132443
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 | 2022-08-04 |
| Device Publish Date | 2022-07-27 |
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 |
Trademark Results [PIEZON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PIEZON 78255916 2901630 Live/Registered |
FERTON HOLDING S.A. 2003-05-29 |
 PIEZON 73360793 1245785 Dead/Cancelled |
E.M.S. Electro Medical Systems S.A. 1982-04-21 |
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