DEVICE: MECTRON (E322035100150)

Device Identifier (DI) Information

MECTRON
IM2A-15
In Commercial Distribution
03510015
MECTRON SPA
E322035100150
HIBCC

1
436664734 *Terms of Use
IM2A-15 is an implant site preparation dental insert to be used in conjunction with Mectron Ultrasonic Piezosurgery handpieces.
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Device Characteristics

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

e80982f7-35d3-4ac7-909d-ac1bf4bf7c40
July 06, 2018
3
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
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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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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+1 6144594922
info@piezosurgery.us
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