DEVICE: MECTRON (E322036000110)

Device Identifier (DI) Information

MECTRON
MT6S-10
In Commercial Distribution
03600011
MECTRON SPA
E322036000110
HIBCC

1
436664734 *Terms of Use
MT6S-10 is an osteotomy surgical insert to be used in conjunction with Mectron Piezosurgery ultrasonic handpieces.
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Device Characteristics

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

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
Hard-tissue ultrasonic surgical system handpiece tip A sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut bone upon contact during an orthopaedic surgical procedure (e.g., spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for surgical waste aspiration and a covering sleeve for delivery of irrigation solution may be included. This is a single-use device.
Dental ultrasonic surgical system handpiece tip A removable endpiece intended to be attached to a dental ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to mechanically fragment and cut bone during dental surgery. The device is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). 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. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
DZI Drill, Bone, Powered
JDX Instrument, Surgical, Sonic And Accessory/Attachment
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K153743 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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

bd2efeef-6d75-45de-90e3-06415dd0da8b
July 24, 2018
4
September 05, 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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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1 6144594922
info@piezosurgery.us
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