Mectron

FDA UDI

Class I (US FDA UDI)

by Mectron Spa

Identity

Trade Name: MECTRON FDA UDI
Generic Name: Dental ultrasonic surgical system FDA UDI
Device Name: Piezosurgery FLEX is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endloscopic visual assistance to perform the above listed procedures. FDA UDI
Model / Reference: PIEZOSURGERY FLEX FDA UDI
Description: Piezosurgery FLEX is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endloscopic visual assistance to perform the above listed procedures. FDA UDI

Identifiers

Catalog Number: 04000095 FDA UDI
Primary DI / UDI-DI: E322040000950 FDA UDI
510(k) Number: K132848 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 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

FDA UDI

Category: Dental ultrasonic surgical system

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.

DS Tip — B&L Biotech Co., Ltd. · Class I
PIEZON MASTER SURGERY — E.M.S. Electro Medical Systems S.A. · Class II
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

Cleared under the same submission

K132848 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 79cecbf7-4cc8-49a1-ba82-461711d88c83 37 fields · synced May 30, 2026