Identity
- Trade Name
- TurboSENSOR® EUDAMEDParkell® FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece FDA UDI
- Device Name
- Handpiece Sheath EUDAMEDParkell® Autoclavable Handpiece Sheath for Turbo 25/30, TurboSENSOR® D560, D590 & D595 FDA UDI
- Model / Reference
- D576 EUDAMEDFDA UDI
- Description
- Parkell® Autoclavable Handpiece Sheath for Turbo 25/30, TurboSENSOR® D560, D590 & D595 FDA UDI
Identifiers
- Catalog Number
- D576 FDA UDI
- Primary DI / UDI-DI
- 00810000520572 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000052SHEATHR5 EUDAMED
- Direct Marketing DI
- 00810000520572 EUDAMED
- FDA Product Code
- ELC FDA UDI
- EMDN Code
- Z12119001 TARTAR ABLATORS EUDAMED
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
TurboSENSOR® by Parkell, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081000052SHEATHR5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parkell Inc.
- EUDAMED SRN
- US-MF-000003761
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (2)
- EUDAMED 1c1ab8e3-ab62-42e2-8bdc-5a80ec38fcda 61 fields · synced Jun 6, 2026
- FDA UDI ebbb4fb0-39f8-4ea4-86ad-f2d78fdc1b39 35 fields · synced May 30, 2026