DEVICE: MECTRON (E322031201341010)

Device Identifier (DI) Information

MECTRON
PS TOUCH COMPLETE HANDPIECE
In Commercial Distribution
03120134-101
MECTRON SPA
E322031201341010
HIBCC

1
436664734 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ultrasonic dental scaling/debridement system handpiece A hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.
Dental ultrasonic surgical system handpiece A hand-held component of a dental ultrasonic surgical system that typically converts high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and cut bone upon contact during dental surgery. The operator regulates the energy with an electric power switch incorporated into a foot-pedal that is attached to the generator. The handpiece typically includes cables and tubing, and may serve as a conduit for irrigation to the site of intervention. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
ELC Scaler, Ultrasonic
DZI Drill, Bone, Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K151248 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

6b1ee072-7cee-4de8-a036-d6ffa20c43f0
July 06, 2018
3
September 02, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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+1 6144594922
info@piezosurgery.us
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