Mectron

FDA UDI

Class II (US FDA UDI)

by Mectron Spa

Identity

Trade Name: MECTRON FDA UDI
Generic Name: Ultrasonic dental scaling/debridement system FDA UDI
Device Name: MT-Bone is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: - Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures; - Scaling applications, including: Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits; o Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning; o Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation; o Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation. FDA UDI
Model / Reference: MT-Bone FDA UDI
Description: MT-Bone is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: - Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures; - Scaling applications, including: Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits; o Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning; o Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation; o Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation. FDA UDI

Identifiers

Catalog Number: 04000132 FDA UDI
Primary DI / UDI-DI: E322040001320 FDA UDI
510(k) Number: K242432 FDA UDI
FDA Product Code: DZI FDA UDI
ELC FDA UDI
GMDN Term: Ultrasonic dental scaling/debridement system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4120 FDA UDI
872.4850 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: Ultrasonic dental scaling/debridement system Dental ultrasonic surgical system

Mectron by Mectron Spa — Class II — 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

K242432 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: Mectron Spa

Sources (1)

FDA UDI 229a929f-aa26-45b2-b67b-bb7dd55381b8 35 fields · synced May 30, 2026