Identity
- Trade Name
- DTE FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
- Device Name
- Cordless Prophy System FDA UDI
- Model / Reference
- i-Polish FDA UDI
- Description
- Cordless Prophy System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944843657721 FDA UDI
- 510(k) Number
- K211531 FDA UDI
- FDA Product Code
- EKX 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
Dte 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
K211531 also covers:
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd.
- woodpecker — Guilin Woodpecker Medical Instrument Co., Ltd.
- woodpecker — Guilin Woodpecker Medical Instrument Co., Ltd.
- Ultrapro TX Cordless — ULTRADENT PRODUCTS, INC.
- Ultrapro TX Cordless — ULTRADENT PRODUCTS, INC.
- Ultrapro TX Cordless — ULTRADENT PRODUCTS, INC.
- Ultrapro TX Cordless — ULTRADENT PRODUCTS, INC.
- Ultrapro TX Cordless — ULTRADENT PRODUCTS, INC.
- Ultrapro TX Cordless — ULTRADENT PRODUCTS, INC.
- Ultrapro TX Cordless — ULTRADENT PRODUCTS, INC.
- Ultrapro TX Cordless — ULTRADENT PRODUCTS, INC.
- Ultrapro TX Cordless — ULTRADENT PRODUCTS, INC.
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 |
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Manufacturer
- Manufacturer
- Guilin Woodpecker Medical Instrument Co., Ltd.
Sources (1)
- FDA UDI 58cfb47a-1544-4e52-ad8e-9b9ba08df374 34 fields · synced May 30, 2026