DEVICE: MECTRON (E322040000990)
Device Identifier (DI) Information
MECTRON
PIEZOSURGERY WHITE
In Commercial Distribution
04000099
MECTRON SPA
PIEZOSURGERY WHITE
In Commercial Distribution
04000099
MECTRON SPA
Piezosurgery White is a piezoelectric device, consisting of handpiece and associated tip inserts, intended for:
1) Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures including implantalogy, 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 debridenient 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;
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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Active | false |
47010 | Dental ultrasonic surgical system |
An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, and a foot-switch to regulate the energy. It is used for implant-site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty and osteotomy.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELC | Scaler, Ultrasonic |
DZI | Drill, Bone, Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K151248 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 60 and 106 KiloPascal |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 10 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9cd22c3a-dfdf-4c41-9903-acbf6ad70bfd
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