DEVICE: MECTRON (E322033800091010)
Device Identifier (DI) Information
MECTRON
OP9 -US
In Commercial Distribution
03380009-101
MECTRON SPA
OP9 -US
In Commercial Distribution
03380009-101
MECTRON SPA
OP9 is a dental Insert for periodontal osseosu surgery to be used in conjunction with Mectron Piezosurgery Ultrasonic handpieces.
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? |
---|---|---|---|---|
47015 | 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
[?]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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
5a07f099-8cb0-4c8e-bad9-ad92f62cbddf
July 06, 2018
3
September 05, 2016
July 06, 2018
3
September 05, 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
[?]
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