DEVICE: MECTRON (E322040000910)

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Device Identifier (DI) Information

MECTRON
COMPACT-PIEZO P2K LED
04000091
MECTRON SPA
E322040000910
HIBCC
1
The COMPACT-PIEZO P2K LED is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications: • Scaling: Procedures for removal of supragingival/subgingival and interdental calculus/plaque deposits; • Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning; • Endodontics: Treatments for root canal reaming irrigation, revision, filling, gutta-percha condensation and retrograde preparation; • Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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 An assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).
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FDA Product Code

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Product Code Product Code Name
ELC Scaler, Ultrasonic
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 70 Degrees Celsius
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 30, 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
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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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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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