Identity
- Trade Name
- PIEZON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- PIEZON 250 FDA UDI
- Model / Reference
- B FDA UDI
- Description
- PIEZON 250 FDA UDI
Identifiers
- Catalog Number
- FT-224#C/009 FDA UDI
- Primary DI / UDI-DI
- 07613353222710 FDA UDI
- 510(k) Number
- K132445 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultrasonic dental scaling/debridement system
Piezon by E.M.S. Electro Medical Systems S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultrasonic dental scaling/debridement system.
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Cleared under the same submission
K132445 also covers:
- Instrument PI starter kit — E.M.S. Electro Medical Systems S.A.
- Instrument PI starter kit — E.M.S. Electro Medical Systems S.A.
- PIEZON — E.M.S. Electro Medical Systems S.A.
- PIEZON — E.M.S. Electro Medical Systems S.A.
- PIEZON — E.M.S. Electro Medical Systems S.A.
- PIEZON — E.M.S. Electro Medical Systems S.A.
- PIEZON — E.M.S. Electro Medical Systems S.A.
- PIEZON — E.M.S. Electro Medical Systems S.A.
- PIEZON — E.M.S. Electro Medical Systems S.A.
- PIEZON — E.M.S. Electro Medical Systems S.A.
- PIEZON — E.M.S. Electro Medical Systems S.A.
- PIEZON — E.M.S. Electro Medical Systems S.A.
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 | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- E.M.S. Electro Medical Systems S.A.
Sources (1)
- FDA UDI 7a92c4e7-41ba-42f4-9ea6-d046f6c2a2ed 36 fields · synced May 31, 2026