Mectron

FDA UDI

Class I (US FDA UDI)

by Mectron Spa

Identity

Trade Name: MECTRON FDA UDI
Generic Name: Dental ultrasonic surgical system handpiece FDA UDI
Device Name: Ultrasonic Medical Handpiece FDA UDI
Model / Reference: PS MEDICAL HANDPIECE FDA UDI
Description: Ultrasonic Medical Handpiece FDA UDI

Identifiers

Catalog Number: 03120127-001 FDA UDI
Primary DI / UDI-DI: E322031201270010 FDA UDI
510(k) Number: K153743 FDA UDI
FDA Product Code: HWE FDA UDI
HBE FDA UDI
ERL FDA UDI
DZI FDA UDI
JDX FDA UDI
GMDN Term: Dental ultrasonic surgical system handpiece FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 FDA UDI
882.4310 FDA UDI
874.4250 FDA UDI
872.4120 FDA UDI
888.4580 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental ultrasonic surgical system handpiece

Mectron by Mectron Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental ultrasonic surgical system handpiece.

PIEZON MASTER SURGERY — E.M.S. Electro Medical Systems S.A. · Class II
WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
ACTEON — Satelec · Class II
PIEZON — E.M.S. Electro Medical Systems S.A. · Class II
Johnson-Promident — Young Innovations, Inc. · Class I
Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
ACTEON — Satelec · Class II
PIEZON MASTER SURGERY — E.M.S. Electro Medical Systems S.A. · Class II

Cleared under the same submission

K153743 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 I	Pending data

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Manufacturer

Manufacturer: Mectron Spa

Sources (1)

FDA UDI 8ff1cb4b-f15d-4591-b7ba-1f53c5fc02a0 36 fields · synced Jun 1, 2026