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: The PIEZOSURGERY FLEX -US 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 -US FDA UDI
Description: The PIEZOSURGERY FLEX -US 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: 05170002-002 FDA UDI
Primary DI / UDI-DI: E322051700020020 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 b30edc00-3b8f-4c5b-86ef-de950e301d5b 37 fields · synced May 30, 2026