DEVICE: MECTRON (E322050900080120)
Device Identifier (DI) Information
MECTRON
COMPACT PIEZO LED -B- DBI
In Commercial Distribution
05090008-012
MECTRON SPA
COMPACT PIEZO LED -B- DBI
In Commercial Distribution
05090008-012
MECTRON SPA
The COMPACT PIEZO LED -B- DBI 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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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36047 | 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
[?]Product Code | Product Code Name |
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ELC | Scaler, Ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K151023 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal |
Storage Environment Temperature: between -10 and 70 Degrees Celsius |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
62e6c033-d437-4ac2-80b3-119ca9ff1875
July 06, 2018
3
August 30, 2016
July 06, 2018
3
August 30, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1 6144594922
info@piezosurgery.us
info@piezosurgery.us