Handpiece with cable 1, 8 M SA-320

FDA UDI

Class II (US FDA UDI)

by W & H Dentalwerk Bürmoos GmbH

Identity

Trade Name: Handpiece with cable 1,8 M SA-320 FDA UDI
Generic Name: Dental ultrasonic surgical system FDA UDI
Device Name: Piezomed Accessories FDA UDI
Model / Reference: 06985000 FDA UDI
Description: Piezomed Accessories FDA UDI

Identifiers

Primary DI / UDI-DI: J021069850001 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental ultrasonic surgical system

Handpiece with cable 1, 8 M SA-320 by W & H Dentalwerk Bürmoos GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental ultrasonic surgical system.

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DTE, WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
TS Tip — B&L Biotech Co., Ltd. · Class I
JETIP Bendable Jig — B&L Biotech Co., Ltd. · Class I
TS Tip — B&L Biotech Co., Ltd. · Class I
BONE TIP HOLDER SET (8 TIPS) — BONART CO., LTD. · Class II
WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II

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: W & H Dentalwerk Bürmoos GmbH

Sources (1)

FDA UDI 74ea3549-e108-40fe-bb9f-4299fa1dc2f2 33 fields · synced May 30, 2026