Identity
- Trade Name
- Paro EUDAMEDInstrument Set "Paro" FDA UDI
- Generic Name
- Dental ultrasonic surgical system handpiece tip FDA UDI
- Device Name
- Piezo Instruments OCI EUDAMEDPiezomed Accessories FDA UDI
- Model / Reference
- 07173400 EUDAMEDFDA UDI
- Description
- Piezomed Accessories FDA UDI
Identifiers
- Primary DI / UDI-DI
- +J021071734001 EUDAMEDJ021071734001 FDA UDI
- Basic UDI-DI
- ++J021S0003R6 EUDAMED
- FDA Product Code
- DZI FDA UDIELC FDA UDI
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Dental ultrasonic surgical system handpiece tip FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4120 FDA UDI872.4850 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental ultrasonic surgical system handpiece tip
Instrument Set "Paro" by W & H Dentalwerk Bürmoos GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental ultrasonic surgical system handpiece tip.
- MECTRON — MECTRON SPA · Class II
- ACTEON — Satelec · Class II
- CI Tip — B&L Biotech Co., Ltd. · Class I
- MECTRON — MECTRON SPA · Class II
- ACTEON — Satelec · Class II
- Vista CT4 (Thin Condensation) Apical Surgery P5 Tip — Vista Dental · Class I
- PIEZON MASTER SURGERY — E.M.S. Electro Medical Systems S.A. · Class II
- PIEZON MASTER SURGERY — E.M.S. Electro Medical Systems S.A. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- W & H Dentalwerk Bürmoos GmbH
Sources (2)
- FDA UDI db2bcd54-ac27-463c-b83d-fa96eb8f988c 33 fields · synced Jul 8, 2026
- EUDAMED 0c9dc766-61eb-471c-bd49-6ff640ade572 61 fields · synced Jul 8, 2026