Identity
- Trade Name
- woodpecker FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
- Device Name
- Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. FDA UDI
- Model / Reference
- Implant Pilot FDA UDI
- Description
- Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944843654942 FDA UDI
- 510(k) Number
- K211358 FDA UDI
- FDA Product Code
- EBW FDA UDI
- GMDN Term
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
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 surgical power tool motorized handpiece/set, electric
woodpecker by Guilin Woodpecker Medical Instrument Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental surgical power tool motorized handpiece/set, electric.
- WE-99 LED G — W & H Dentalwerk Bürmoos GmbH · Class I
- S-9 LG surgical handpiece 1:1 — W & H Dentalwerk Bürmoos GmbH · Class II
- WG-57 LT — W & H Dentalwerk Bürmoos GmbH · Class I
- MAXSO — Beyes Dental Canada Inc · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Medidenta — Medidenta · Class I
- StarDental — DENTALEZ, INC. · Class I
- StarDental Instrument Solutions — DENTALEZ, INC. · Class I
Cleared under the same submission
K211358 also covers:
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- woodpecker — Guilin Woodpecker Medical Instrument Co., Ltd.
- woodpecker — Guilin Woodpecker Medical Instrument Co., Ltd.
- woodpecker — Guilin Woodpecker Medical Instrument Co., Ltd.
- woodpecker — Guilin Woodpecker Medical Instrument Co., Ltd.
- woodpecker — Guilin Woodpecker Medical Instrument Co., Ltd.
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guilin Woodpecker Medical Instrument Co., Ltd.
Sources (1)
- FDA UDI a675e674-713b-40fe-b107-147ce44b230d 34 fields · synced May 30, 2026