Dte

FDA UDI

Class II (US FDA UDI)

by Guilin Woodpecker Medical Instrument Co., Ltd.

Identity

Trade Name: DTE FDA UDI
Generic Name: Dental abrasive air jet system FDA UDI
Device Name: Dental Scaler and Air Polisher FDA UDI
Model / Reference: PT-B FDA UDI
Description: Dental Scaler and Air Polisher FDA UDI

Identifiers

Primary DI / UDI-DI: 06944843655987 FDA UDI
510(k) Number: K203615 FDA UDI
FDA Product Code: ELC FDA UDI
KOJ FDA UDI
GMDN Term: Dental abrasive air jet system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4850 FDA UDI
872.6080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Ultrasonic dental scaling/debridement system Dental abrasive air jet system

Dte by Guilin Woodpecker Medical Instrument Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental abrasive air jet system.

AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class I
AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class I
AIR-FLOW-PIEZON — E.M.S. Electro Medical Systems S.A. · Class II
AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class II
AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class I
Cavitron® — Dentsply Professional · Class II
AIR-FLOW-PIEZON — E.M.S. Electro Medical Systems S.A. · Class II
JETPOLISHER 2000 — DELDENT LTD. · Class II

Cleared under the same submission

K203615 also covers:

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 a366f862-ae34-468c-8436-902b43658f09 34 fields · synced Jun 8, 2026