Identity
- Trade Name
- DTE FDA UDI
- Generic Name
- Dental ultrasonic surgical system FDA UDI
- Device Name
- Dental ultrasonic surgical system FDA UDI
- Model / Reference
- Surgery-X LED FDA UDI
- Description
- Dental ultrasonic surgical system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944843603971 FDA UDI
- 510(k) Number
- K111290 FDA UDI
- FDA Product Code
- DZI FDA UDI
- GMDN Term
- Dental ultrasonic surgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental ultrasonic surgical system
Dte by Guilin Woodpecker Medical Instrument Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental ultrasonic surgical system.
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- TS Tip — B&L Biotech Co., Ltd. · Class I
- BONE TIP HOLDER SET (8 TIPS) — BONART CO., LTD. · Class II
- ACTEON — Satelec · Class II
- BONE TIP/BM-EL3 — BONART CO., LTD. · Class II
Cleared under the same submission
K111290 also covers:
- BenTips Insert WPUI3A — BENNETT JACOBY, DDS, MS, INC.
- BenTips Insert WPUI4A — BENNETT JACOBY, DDS, MS, INC.
- BenTips Insert WPUI5A — BENNETT JACOBY, DDS, MS, INC.
- BenTips Insert WPUI6A — BENNETT JACOBY, DDS, MS, INC.
- BenTips Insert WPUI7A — BENNETT JACOBY, DDS, MS, INC.
- BenTips Insert WPUP2A — BENNETT JACOBY, DDS, MS, INC.
- BenTips Insert WPUP3A — BENNETT JACOBY, DDS, MS, INC.
- BenTips Insert WPUP4A — BENNETT JACOBY, DDS, MS, INC.
- BenTips Insert WPUP6A — BENNETT JACOBY, DDS, MS, INC.
- BenTips Insert WPUP7A — BENNETT JACOBY, DDS, MS, INC.
- BenTips Piezosurgery Handpiece — BENNETT JACOBY, DDS, MS, INC.
- BenTips Piezosurgery System — BENNETT JACOBY, DDS, MS, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Guilin Woodpecker Medical Instrument Co., Ltd.
Sources (1)
- FDA UDI bc0ca28d-779a-4c42-812a-d0a0e225c9f5 34 fields · synced May 30, 2026