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: The MULTIPIEZO PRO -basic -US- is a piezoelectric ultrasonic dental scaler intended for use, with the appropriate associated tip inserts, in the following dental applications: •Scaling:All general procedures for removal of supragingival/subgingival and interdental calculus/ plaque deposits; •Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning; •Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation; •Restorative and Prosthetics: All general restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation, implants/restorations cleaning. FDA UDI
Model / Reference: MULTIPIEZO PRO -basic -US- FDA UDI
Description: The MULTIPIEZO PRO -basic -US- is a piezoelectric ultrasonic dental scaler intended for use, with the appropriate associated tip inserts, in the following dental applications: •Scaling:All general procedures for removal of supragingival/subgingival and interdental calculus/ plaque deposits; •Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning; •Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation; •Restorative and Prosthetics: All general restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation, implants/restorations cleaning. FDA UDI

Identifiers

Catalog Number: 05060022-021 FDA UDI
Primary DI / UDI-DI: E322050600220210 FDA UDI
510(k) Number: K140965 FDA UDI
FDA Product Code: ELC FDA UDI
GMDN Term: Ultrasonic dental scaling/debridement system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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

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Cleared under the same submission

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 5f533cf9-ee11-4609-afbe-3e5c60cc46d5 37 fields · synced Jun 8, 2026