MECTRON - Piezosurgery Touch -essential -US- is a - MECTRON SPA

Duns Number:436664734

Device Description: Piezosurgery Touch -essential -US- is a piezoelectric ultrasonic device, consisting of han Piezosurgery Touch -essential -US- is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: ·1) Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;2) Scaling applications, including:• Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;• Perlodontology: 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: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

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More Product Details

Catalog Number

05120062-028

Brand Name

MECTRON

Version/Model Number

PIEZOSURGERY ® TOUCH -essential -US-

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122322

Product Code Details

Product Code

DZI

Product Code Name

Drill, Bone, Powered

Device Record Status

Public Device Record Key

a5035da3-ed6c-438c-a3d1-9596cc98393b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MECTRON SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 45
2 A medical device with a moderate to high risk that requires special controls. 199