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Dental Scaler and Air Polisherh
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref APB0256Model AP-B
Identity
- Trade Name
- Dental Scaler and Air Polisherh EUDAMEDwoodpecker FDA UDI
- Generic Name
- Dental abrasive air jet system FDA UDI
- Device Name
- Dental Scaler and Air Polisher FDA UDI
- Model / Reference
- AP-B EUDAMEDFDA UDIAPB0256 EUDAMED
- Description
- Dental Scaler and Air Polisher FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944843611600 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06944843611600 EUDAMED
- 510(k) Number
- K203615 FDA UDI
- FDA Product Code
- ELC FDA UDIKOJ FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Dental abrasive air jet system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4850 FDA UDI872.6080 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental delivery system
Dental Scaler and Air Polisherh by Guilin Woodpecker Medical Instrument Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203615 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06944843611600 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guilin Woodpecker Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000009139
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 9474a0fc-19bd-4747-bff5-13f582c8913c 61 fields · synced Oct 6, 2026
- FDA UDI 818ff494-3a2b-41b1-b98c-17de2ae18ad5 34 fields · synced May 30, 2026
- FDA 510(k) K203615 1 fields · synced May 18, 2026