Identity
- Trade Name
- Piezon FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- PIEZON® NO PAIN Built in kit LED 24-32V DC / 24V AC 50-60Hz 18VA With EJ-120A/B and EL-457, without EH-128 and external power supply + IFU FB-358/NA and FB-536/NA FDA UDI
- Model / Reference
- FS-367#E/101 FDA UDI
- Description
- PIEZON® NO PAIN Built in kit LED 24-32V DC / 24V AC 50-60Hz 18VA With EJ-120A/B and EL-457, without EH-128 and external power supply + IFU FB-358/NA and FB-536/NA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07613353317430 FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ultrasonic dental scaling/debridement system
Piezon by E.M.S. Electro Medical Systems S.A. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- E.M.S. Electro Medical Systems S.A.
Sources (1)
- FDA UDI 66ba0846-157a-48ae-a0dd-97961e8adb07 34 fields · synced Jun 8, 2026