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Mectron

FDA UDI

Class II (US FDA UDI)

by Mectron Spa

Identity

Trade Name
MECTRON FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system handpiece FDA UDI
Device Name
Piezoelectric ultrasonic handpiece with cord to be used in conjunction with Mectron Piezosurgery devices and tip inserts for the following applications: 1) Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures.including implantalogy, periodontal surgery, surgical orthodontic, and surgical endodonticprocedures; 2) Scaling applications, including: - Scaling: All general procedures for removal of supragingival and interdental calculus & plaquedeposits - Periodontology: Periodontal therapy and debridenient for all types of periodontal diseases,including periodontal pocket irrigation and cleaning: - Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-perchacondensation and retrograde preparation; - Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation. FDA UDI
Model / Reference
PS TOUCH COMPLETE HANDPIECE FDA UDI
Description
Piezoelectric ultrasonic handpiece with cord to be used in conjunction with Mectron Piezosurgery devices and tip inserts for the following applications: 1) Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures.including implantalogy, periodontal surgery, surgical orthodontic, and surgical endodonticprocedures; 2) Scaling applications, including: - Scaling: All general procedures for removal of supragingival and interdental calculus & plaquedeposits - Periodontology: Periodontal therapy and debridenient for all types of periodontal diseases,including periodontal pocket irrigation and cleaning: - Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-perchacondensation and retrograde preparation; - Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation. FDA UDI

Identifiers

Catalog Number
03120134-101 FDA UDI
Primary DI / UDI-DI
E322031201341010 FDA UDI
510(k) Number
K151248 FDA UDI
FDA Product Code
ELC FDA UDI
DZI FDA UDI
GMDN Term
Ultrasonic dental scaling/debridement system handpiece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4850 FDA UDI
872.4120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic dental scaling/debridement system handpieceDental ultrasonic surgical system handpiece

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 handpiece.

Cleared under the same submission

K151248 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mectron Spa

Sources (1)

  • FDA UDI 6b1ee072-7cee-4de8-a036-d6ffa20c43f0 36 fields · synced Jun 8, 2026